Medical device recalls: October 2005
The FDA posted 112 medical device recall records in October 2005, from 55 recall events by 48 companies. 112 have not been classified yet.
Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.
Companies with the most recall events
- Stryker Howmedica Osteonics Corp. · 3 events, 4 records
- Zimmer Inc. · 2 events, 9 records
- Medrad Inc · 2 events, 3 records
- Nichols Institute Diagnostics · 2 events, 3 records
- Abbott Laboratories, Inc · 2 events, 2 records
- Baxter Healthcare Corp. · 2 events, 2 records
- Abbott Laboratories Medisense Products · 1 event, 13 records
- Becton Dickinson Medical Systems · 1 event, 7 records
FDA root cause
- Other · 108
- Software design · 2
- Process control · 2
Not yet classified (112)
The FDA has posted these records but has not published a class for them yet.
- Z-0040-06 · Boston Scientific Corporation · posted Oct 28, 2005 · Terminated
Incorrect implantation may cause serious health complications
- Z-0041-06 · Boston Scientific Corporation · posted Oct 28, 2005 · Terminated
Incorrect implantation may cause serious health complications
- Z-0090-06 · Vygon Corporation · posted Oct 28, 2005 · Terminated
Guidewire protuding from tip of the catheter
- Z-0091-06 · Zimmer Inc. · posted Oct 28, 2005 · Terminated
The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique.
- Z-0092-06 · Siemens Medical Solutions USA, Inc · posted Oct 28, 2005 · Terminated
reference lines appear above actual position
- Z-0093-06 · Advanced Medical Optics, Inc. · posted Oct 28, 2005 · Terminated
A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile…
- Z-0094-06 · Advanced Medical Optics, Inc. · posted Oct 28, 2005 · Terminated
A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile…
- Z-0095-06 · Advanced Medical Optics, Inc. · posted Oct 28, 2005 · Terminated
A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile…
- Z-0096-06 · Advanced Medical Optics, Inc. · posted Oct 28, 2005 · Terminated
A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile…
- Z-0097-06 · Advanced Medical Optics, Inc. · posted Oct 28, 2005 · Terminated
A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile…
- Z-0098-06 · Roche Diagnostics Corp. · posted Oct 28, 2005 · Terminated
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
- Z-0099-06 · Roche Diagnostics Corp. · posted Oct 28, 2005 · Terminated
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
- Z-0100-06 · Roche Diagnostics Corp. · posted Oct 28, 2005 · Terminated
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
- Z-0101-06 · Lifescan Inc · posted Oct 28, 2005 · Terminated
The LCD of the OneTouch SureStep Meter may display incorrectly, resulting in missing segments on the display. This display failure may result in patients misreading the blood glucose result, or cause a delay in test interpretation, and could cause delays…
- Z-0102-06 · Accumetrics Inc · posted Oct 28, 2005 · Terminated
In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply.
- Z-0103-06 · Medical Components, Inc dba MedComp · posted Oct 28, 2005 · Terminated
The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F
- Z-0104-06 · Medical Components, Inc dba MedComp · posted Oct 28, 2005 · Terminated
The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F
- Z-0105-06 · General Electric Med Systems LLC · posted Oct 28, 2005 · Terminated
Cracked welds on the main rotation shaft could potentially lead to the collapse of the gantry yokes that support the detectors if the system is continued to be used after the weld has completely fractured.
- Z-0089-06 · Medrad Inc · posted Oct 25, 2005 · Terminated
overhead system can fall due to the failure of a retaining ring.
- Z-0032-06 · Biomerieux, Inc. · posted Oct 22, 2005 · Terminated
The product is being recalled due to mis-assignment of ISI values associated with VeriCal use.
- Z-0086-06 · Greiner VACUETTE North America · posted Oct 22, 2005 · Terminated
Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.
- Z-0087-06 · Hamilton Co · posted Oct 22, 2005 · Terminated
The product valve has a high probability of deforming and may result in leakage during use.
- Z-0088-06 · Misys Healthcare Systems · posted Oct 22, 2005 · Terminated
Customer complaint during testing of module prior to production use. Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000, the system willfile the number 100 instead of number 100,000.
- Z-0042-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0043-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0044-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0045-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0046-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0047-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0048-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0049-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0050-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0051-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0052-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0053-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0054-06 · Abbott Laboratories Medisense Products · posted Oct 21, 2005 · Terminated
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Z-0065-06 · Remington Medical Inc. · posted Oct 21, 2005 · Terminated
The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.
- Z-0066-06 · Remington Medical Inc. · posted Oct 21, 2005 · Terminated
The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.
- Z-0067-06 · Remington Medical Inc. · posted Oct 21, 2005 · Terminated
The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.
- Z-0068-06 · Philips Medical Systems (Cleveland) Inc · posted Oct 21, 2005 · Terminated
The image balance center point correction algorithm used in CT image reconstruction may cause a disapperance or alteration of small circular anatomical structures that are both near the image center and perpendicular to the image plane. This artifact may…
- Z-0069-06 · Becton Dickinson Medical Systems · posted Oct 21, 2005 · Terminated
Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Z-0070-06 · Becton Dickinson Medical Systems · posted Oct 21, 2005 · Terminated
Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Z-0071-06 · Becton Dickinson Medical Systems · posted Oct 21, 2005 · Terminated
Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Z-0072-06 · Becton Dickinson Medical Systems · posted Oct 21, 2005 · Terminated
Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Z-0073-06 · Becton Dickinson Medical Systems · posted Oct 21, 2005 · Terminated
Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Z-0074-06 · Becton Dickinson Medical Systems · posted Oct 21, 2005 · Terminated
Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Z-0075-06 · Becton Dickinson Medical Systems · posted Oct 21, 2005 · Terminated
Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Z-0076-06 · Ethicon, Inc · posted Oct 21, 2005 · Terminated
Two lots of J-VAC Drain Reservors were shipped to Japan prior to sterilization and were released.
- Z-0077-06 · Merit Medical Systems, Inc · posted Oct 21, 2005 · Terminated
Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
- Z-0078-06 · Merit Medical Systems, Inc · posted Oct 21, 2005 · Terminated
Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
- Z-0079-06 · Merit Medical Systems, Inc · posted Oct 21, 2005 · Terminated
Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
- Z-0080-06 · Merit Medical Systems, Inc · posted Oct 21, 2005 · Terminated
Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
- Z-0081-06 · Merit Medical Systems, Inc · posted Oct 21, 2005 · Terminated
Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
- Z-0082-06 · Medrad Inc · posted Oct 21, 2005 · Terminated
stress crack on the stopcock
- Z-0083-06 · Medrad Inc · posted Oct 21, 2005 · Terminated
stress crack on the stopcock
- Z-0084-06 · D.T. Davis Enterprises Ltd. · posted Oct 21, 2005 · Terminated
Instructions for use are not adhering to the product
- Z-0085-06 · Surgical Specialties Corp · posted Oct 21, 2005 · Terminated
mislabeled as double armed straight needle actually single armed straight needle
- Z-0064-06 · Boston Scientific · posted Oct 19, 2005 · Terminated
The device has the potential for overheating its transformer and has the potential for fire hazard.
- Z-0055-06 · Origen Biomedical, Inc · posted Oct 15, 2005 · Terminated
Leak between two lumens causes reduced performance.
- Z-0056-06 · Nichols Institute Diagnostics · posted Oct 15, 2005 · Terminated
Controls were out of specification range.
- Z-0057-06 · Biosense Webster, Inc. · posted Oct 15, 2005 · Terminated
Increased complaints regarding catheters with leaks and flow obstruction.
- Z-0058-06 · Stryker Howmedica Osteonics Corp. · posted Oct 15, 2005 · Terminated
The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.
- Z-0059-06 · Stryker Howmedica Osteonics Corp. · posted Oct 15, 2005 · Terminated
The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.
- Z-0060-06 · Stryker Howmedica Osteonics Corp. · posted Oct 15, 2005 · Terminated
The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility.
- Z-0061-06 · Baxter Healthcare Corp. · posted Oct 15, 2005 · Terminated
If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached to a medication in the drug file, a Point of Care end user will be unable to enter monitoring parameter results on the handheld.
- Z-0062-06 · Event Medical · posted Oct 15, 2005 · Terminated
Firm received reports of combustion within the blender system of the Inspiration Ventilator.
- Z-0187-05 · Invision Technologies Inc · posted Oct 15, 2005 · Terminated
X-ray leakage exceed exposure standard of 0.5 mR/hr.
- Z-0034-06 · Stryker Instruments Div. of Stryker Corporation · posted Oct 12, 2005 · Terminated
The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.
- Z-0035-06 · Analogic Corporation · posted Oct 12, 2005 · Terminated
Unit may not power up due to faulty circuit board
- Z-0036-06 · Analogic Corporation · posted Oct 12, 2005 · Terminated
Unit may not power up due to faulty circuit board
- Z-0037-06 · Datex-Ohmeda Inc · posted Oct 12, 2005 · Terminated
Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead…
- Z-0038-06 · Datex-Ohmeda Inc · posted Oct 12, 2005 · Terminated
Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead…
- Z-0039-06 · Datex-Ohmeda Inc · posted Oct 12, 2005 · Terminated
Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead…
- Z-0033-06 · Baxter Healthcare Corp. · posted Oct 8, 2005 · Terminated
If a pharmacy end user alters the Administration Unit of Measure (AUOM) of an ordered drug, the AUOM will display incorrectly on the Medication Administration Record for the patient, possibly leading to medication errors.
- Z-0011-06 · Stryker Howmedica Osteonics Corp. · posted Oct 7, 2005 · Terminated
Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.
- Z-0012-06 · Ebi, L.P. · posted Oct 7, 2005 · Terminated
Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.
- Z-0013-06 · Plus Orthopedics USA · posted Oct 7, 2005 · Terminated
Did not meet specifications.
- Z-0014-06 · Plus Orthopedics USA · posted Oct 7, 2005 · Terminated
Did not meet specifications.
- Z-0015-06 · Plus Orthopedics USA · posted Oct 7, 2005 · Terminated
Did not meet specifications.
- Z-0016-06 · Plus Orthopedics USA · posted Oct 7, 2005 · Terminated
Did not meet specifications.
- Z-0017-06 · Plus Orthopedics USA · posted Oct 7, 2005 · Terminated
Did not meet specifications.
- Z-0018-06 · Plus Orthopedics USA · posted Oct 7, 2005 · Terminated
Did not meet specifications.
- Z-0019-06 · Plus Orthopedics USA · posted Oct 7, 2005 · Terminated
Did not meet specifications.
- Z-0020-06 · Pioneer Surgical Technology · posted Oct 7, 2005 · Terminated
Screw may be incorrectly etched as to length.
- Z-0021-06 · Pioneer Surgical Technology · posted Oct 7, 2005 · Terminated
Screw may be incorrectly etched as to length.
- Z-0023-06 · Zimmer Inc. · posted Oct 7, 2005 · Terminated
The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Z-0024-06 · Zimmer Inc. · posted Oct 7, 2005 · Terminated
The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Z-0025-06 · Zimmer Inc. · posted Oct 7, 2005 · Terminated
The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Z-0026-06 · Zimmer Inc. · posted Oct 7, 2005 · Terminated
The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Z-0027-06 · Zimmer Inc. · posted Oct 7, 2005 · Terminated
The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Z-0028-06 · Zimmer Inc. · posted Oct 7, 2005 · Terminated
The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Z-0029-06 · Zimmer Inc. · posted Oct 7, 2005 · Terminated
The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Z-0030-06 · Zimmer Inc. · posted Oct 7, 2005 · Terminated
The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Z-0031-06 · Rita Medical Systems · posted Oct 7, 2005 · Terminated
Devices for which sterility may be compromised as evidenced by a loss of package integrity.
- Z-0006-06 · Nichols Institute Diagnostics · posted Oct 6, 2005 · Terminated
Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its…
- Z-0007-06 · Nichols Institute Diagnostics · posted Oct 6, 2005 · Terminated
Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its…
- Z-0008-06 · Abbott Laboratories, Inc · posted Oct 6, 2005 · Terminated
Device has incorrect notation associated with therapeutic drug monitoring assays.
- Z-0009-06 · Beckman Coulter Inc · posted Oct 6, 2005 · Terminated
Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced…
- Z-0010-06 · Abbott Laboratories, Inc · posted Oct 6, 2005 · Terminated
Software deficiency causing potential shift in absorbance readings for test results.
- Z-0001-06 · VIASYS Med Systems · posted Oct 4, 2005 · Terminated
The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
- Z-0002-06 · VIASYS Med Systems · posted Oct 4, 2005 · Terminated
The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
- Z-0003-06 · B. Braun Medical, Inc. · posted Oct 4, 2005 · Terminated
package sealing defect - product may not be sterile
- Z-0004-06 · Medtronic Emergency Response Systems, Inc. · posted Oct 4, 2005 · Terminated
Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).
- Z-0005-06 · Medtronic Emergency Response Systems, Inc. · posted Oct 4, 2005 · Terminated
Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).
- Z-1545-05 · Gambro Renal Products · posted Oct 1, 2005 · Terminated
Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss.
- Z-1576-05 · Diasorin Inc. · posted Oct 1, 2005 · Terminated
An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.
- Z-1593-05 · Cryolife Inc · posted Oct 1, 2005 · Terminated
Mislabeling; An allograft labeled as an aortic valve & conduit, actually contained a pulmonary valve and conduit.
- Z-1594-05 · Abbott Diabetes Care, Inc. · posted Oct 1, 2005 · Terminated
Downloadable software obtained from the firm's website displays user data (including but not limited to insulin levels and pump statistics data) in a matter that may be misinterpreted and result in mistreatment of therapy.
- Z-1595-05 · Oasis Medical Inc · posted Oct 1, 2005 · Terminated
"Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators
- Z-1599-05 · Oasis Medical Inc · posted Oct 1, 2005 · Terminated
"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency". Foreign deposit present on the…
- Z-1600-05 · Oasis Medical Inc · posted Oct 1, 2005 · Terminated
"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency". Foreign deposit present on the…
- Z-1601-05 · Oasis Medical Inc · posted Oct 1, 2005 · Terminated
"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency". Foreign deposit present on the…
Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.