Medical device recalls: April 2007
The FDA posted 62 medical device recall records in April 2007, from 42 recall events by 34 companies. 62 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
- Abbott Laboratories · 3 events, 3 records
- Diasorin Inc. · 3 events, 3 records
- Siemens Medical Solutions USA, Inc · 2 events, 4 records
- Bausch & Lomb Inc · 2 events, 3 records
- Roche Diagnostics Corp. · 2 events, 2 records
- Smiths Medical MD, Inc. · 2 events, 2 records
- BioHorizons Implant Systems Inc · 1 event, 4 records
- Cenorin · 1 event, 3 records
FDA root cause
- Other · 62
Not yet classified (62)
The FDA has posted these records but has not published a class for them yet.
- Z-0768-2007 · Smiths Medical MD, Inc. · posted Apr 26, 2007 · Terminated
Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine.…
- Z-0769-2007 · Siemens Medical Solutions USA, Inc · posted Apr 26, 2007 · Terminated
If table top is not seated properly it can lock up/stick.
- Z-0755-2007 · Diasorin Inc. · posted Apr 24, 2007 · Terminated
A lot to lot inconsistency was noted on kits of ETI EBNA G.
- Z-0756-2007 · Conmed Corporation · posted Apr 24, 2007 · Terminated
Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their…
- Z-0757-2007 · Conmed Corporation · posted Apr 24, 2007 · Terminated
Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their…
- Z-0759-2007 · Medi Manufacturing Inc · posted Apr 24, 2007 · Terminated
Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications.
- Z-0760-2007 · Nellcor Puritan Bennett · posted Apr 24, 2007 · Terminated
In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does not reset, the ventilator will detect a circuit disconnect condition. When this happens, the ventilator will annunciate a high-urgency audible…
- Z-0731-2007 · Sunrise Medical · posted Apr 21, 2007 · Terminated
Cylinder could lose oxygen at high pressure after the filling process
- Z-0732-2007 · Sunrise Medical · posted Apr 21, 2007 · Terminated
Cylinder could lose oxygen at high pressure after the filling process
- Z-0765-2007 · Bausch & Lomb Inc · posted Apr 21, 2007 · Terminated
The cutter probe tip breaks during use.
- Z-0766-2007 · Bausch & Lomb Inc · posted Apr 21, 2007 · Terminated
The cutter probe tip breaks during use.
- Z-0767-2007 · Miltex, Inc. · posted Apr 21, 2007 · Terminated
Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex)
- Z-0761-2007 · Bio-Logic Systems Corp · posted Apr 20, 2007 · Terminated
Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating.
- Z-0749-2007 · Siemens Medical Solutions USA, Inc · posted Apr 19, 2007 · Terminated
Mounting bolts for tank fork assembly and collimator flange may become loose.
- Z-0750-2007 · Siemens Medical Solutions USA, Inc · posted Apr 19, 2007 · Terminated
Mounting bolts for tank fork assembly and collimator flange may become loose.
- Z-0751-2007 · Siemens Medical Solutions USA, Inc · posted Apr 19, 2007 · Terminated
Mounting bolts for tank fork assembly and collimator flange may become loose.
- Z-0752-2007 · Rita Medical Systems, Inc. · posted Apr 19, 2007 · Terminated
The product may have a cracked tray which can compromise the sterility of the product.
- Z-0753-2007 · Rita Medical Systems, Inc. · posted Apr 19, 2007 · Terminated
The product may have a cracked tray which can compromise the sterility of the product.
- Z-0754-2007 · Rita Medical Systems, Inc. · posted Apr 19, 2007 · Terminated
The product may have a cracked tray which can compromise the sterility of the product.
- Z-0743-2007 · Mega Diagnostics · posted Apr 14, 2007 · Terminated
Potential for microorganism growth in the alcohol standard and or unexpected QC changes in the Ammonia portion of the Ammonia/Alcohol control product.
- Z-0744-2007 · Mega Diagnostics · posted Apr 14, 2007 · Terminated
Potential for microorganism growth in the alcohol standard.
- Z-0745-2007 · Boston Scientific Corp · posted Apr 14, 2007 · Terminated
Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by supplier B. Braun Medical of the error)
- Z-0746-2007 · Boston Scientific Corp · posted Apr 14, 2007 · Terminated
Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by their supplier B. Braun Medical of the error)
- Z-0747-2007 · Ortho-Clinical Diagnostics · posted Apr 14, 2007 · Terminated
Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types.
- Z-0748-2007 · Diasorin Inc. · posted Apr 14, 2007 · Terminated
Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
- Z-0692-2007 · BioHorizons Implant Systems Inc · posted Apr 13, 2007 · Terminated
Premature wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
- Z-0693-2007 · BioHorizons Implant Systems Inc · posted Apr 13, 2007 · Terminated
Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
- Z-0694-2007 · BioHorizons Implant Systems Inc · posted Apr 13, 2007 · Terminated
Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
- Z-0736-2007 · Roche Diagnostics Corp. · posted Apr 13, 2007 · Terminated
The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots.
- Z-1164-2007 · BioHorizons Implant Systems Inc · posted Apr 13, 2007 · Terminated
Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
- Z-0729-2007 · Conmed Endoscopic Technologies, Inc. · posted Apr 11, 2007 · Terminated
Blue safety clip incorrectly placed on the stent may prevent deployment
- Z-0730-2007 · Conmed Endoscopic Technologies, Inc. · posted Apr 11, 2007 · Terminated
Blue safety clip incorrectly placed on the stent may prevent deployment
- Z-0734-2007 · Roche Molecular Systems, Inc. · posted Apr 11, 2007 · Terminated
The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I rec., RNase-free, P/N 04716728001 (Roche Applied Science)" . The Part Number…
- Z-0735-2007 · Roche Molecular Systems, Inc. · posted Apr 11, 2007 · Terminated
The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I rec., RNase-free, P/N 04716728001 (Roche Applied Science)" . The Part Number…
- Z-0737-2007 · Roche Diagnostics Corp. · posted Apr 11, 2007 · Terminated
The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
- Z-0733-2007 · Bio-Rad Laboratories Inc · posted Apr 10, 2007 · Terminated
The product may produce a faint line which could be interpreted as a false negative test result .
- Z-0723-2007 · Hamilton Co · posted Apr 7, 2007 · Terminated
Some of the packaged tips have increased force during aspiration, which can lead to pipetting errors such as LLD error messages, and also has risk of causing a missed pipetting.
- Z-0724-2007 · Smith & Nephew, Inc. Endoscopy Division · posted Apr 7, 2007 · Terminated
Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.
- Z-0725-2007 · Smith & Nephew, Inc. Endoscopy Division · posted Apr 7, 2007 · Terminated
Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.
- Z-0726-2007 · Smith & Nephew, Inc. Endoscopy Division · posted Apr 7, 2007 · Terminated
Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.
- Z-0727-2007 · Joerns Healthcare Inc. · posted Apr 7, 2007 · Terminated
Unapproved Design Change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds).
- Z-0728-2007 · Abbott Laboratories · posted Apr 7, 2007 · Terminated
A small number of reagent kits were incorrectly configured. The affected kits contain either two bottles of conjugate or two bottles of assay diluent instead of one bottle of each.
- Z-0705-2007 · Radiometer America Inc · posted Apr 6, 2007 · Terminated
In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.
- Z-0674-2007 · Draeger Medical, Inc. · posted Apr 5, 2007 · Terminated
Compressors not providing sufficient supply pressure to connected medical ventilator
- Z-0718-2007 · Smiths Medical MD, Inc. · posted Apr 5, 2007 · Terminated
The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm…
- Z-0719-2007 · Becton Dickinson & Company · posted Apr 5, 2007 · Terminated
The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size.
- Z-0720-2007 · Urologix, Inc. · posted Apr 5, 2007 · Terminated
The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.
- Z-0721-2007 · Urologix, Inc. · posted Apr 5, 2007 · Terminated
The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.
- Z-0722-2007 · Abbott Laboratories Inc. · posted Apr 5, 2007 · Terminated
Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L)
- Z-0710-2007 · Coloplast Corp Skin Care Div · posted Apr 4, 2007 · Terminated
Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).
- Z-0711-2007 · Cenorin · posted Apr 4, 2007 · Terminated
Potential for user to receive an electrical shock.
- Z-0712-2007 · Cenorin · posted Apr 4, 2007 · Terminated
Potential for user to receive an electrical shock.
- Z-0713-2007 · Cenorin · posted Apr 4, 2007 · Terminated
Potential for user to receive an electrical shock.
- Z-0714-2007 · Integra Biotechnical LLC · posted Apr 4, 2007 · Terminated
During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters.
- Z-0715-2007 · Bausch & Lomb Inc · posted Apr 4, 2007 · Terminated
A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.
- Z-0716-2007 · Pulse Biomedical Inc · posted Apr 4, 2007 · Terminated
No 510(k) marketing clearance for the product
- Z-0701-2007 · Scanlan International Inc · posted Apr 3, 2007 · Terminated
Incorrectly assembled by manufacturer
- Z-0702-2007 · American Medical Systems · posted Apr 3, 2007 · Terminated
Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
- Z-0703-2007 · American Medical Systems · posted Apr 3, 2007 · Terminated
Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
- Z-0706-2007 · Abbott Laboratories · posted Apr 3, 2007 · Terminated
Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range
- Z-0707-2007 · Diasorin Inc. · posted Apr 3, 2007 · Terminated
Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered invalid)
- Z-0708-2007 · Abbott Laboratories · posted Apr 3, 2007 · Terminated
High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.
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.