Medical device recalls: November 2017
The FDA posted 19 medical device recall records in November 2017, from 7 recall events by 6 companies. 1 is Class I, the most serious category.
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
- Medline Industries Inc · 2 events, 3 records
- Halyard Health, Inc · 1 event, 9 records
- Encore Medical, Lp · 1 event, 4 records
- Becton Dickinson & Company · 1 event, 1 record
- ICU Medical, Inc. · 1 event, 1 record
- Spacelabs Healthcare, Ltd. · 1 event, 1 record, 1 Class I
FDA root cause
- Under Investigation by firm · 9
- Vendor change control · 4
- Employee error · 2
- Software design · 1
- Packaging · 1
- Manufacturing material removal · 1
- Labeling mix-ups · 1
Class I recalls (1)
The most serious: a reasonable probability that using the device will cause serious health problems or death.
- Z-0072-2018 · Spacelabs Healthcare, Ltd. · posted Nov 21, 2017 · Terminated
Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms.
Class II recalls (18)
The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
- Z-0183-2018 · Becton Dickinson & Company · posted Nov 28, 2017 · Terminated
Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle mL 8mm 31G, Cat (Ref) 328468. The shelf carton…
- Z-0162-2018 · Medline Industries Inc · posted Nov 21, 2017 · Terminated
Possible open seal on top portion of the package. Could cause breach of sterility.
- Z-0112-2018 · Medline Industries Inc · posted Nov 18, 2017 · Terminated
Products labeled as sterile were distributed prior to sterilization
- Z-0113-2018 · Medline Industries Inc · posted Nov 18, 2017 · Terminated
Products labeled as sterile were distributed prior to sterilization
- Z-0117-2018 · Halyard Health, Inc · posted Nov 18, 2017 · Terminated
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- Z-0118-2018 · Halyard Health, Inc · posted Nov 18, 2017 · Terminated
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- Z-0119-2018 · Halyard Health, Inc · posted Nov 18, 2017 · Terminated
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- Z-0120-2018 · Halyard Health, Inc · posted Nov 18, 2017 · Terminated
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- Z-0121-2018 · Halyard Health, Inc · posted Nov 18, 2017 · Terminated
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- Z-0122-2018 · Halyard Health, Inc · posted Nov 18, 2017 · Terminated
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- Z-0123-2018 · Halyard Health, Inc · posted Nov 18, 2017 · Terminated
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- Z-0124-2018 · Halyard Health, Inc · posted Nov 18, 2017 · Terminated
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- Z-0125-2018 · Halyard Health, Inc · posted Nov 18, 2017 · Terminated
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
- Z-0106-2018 · ICU Medical, Inc. · posted Nov 17, 2017 · Terminated
ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.
- Z-0064-2018 · Encore Medical, Lp · posted Nov 6, 2017 · Open, Classified
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
- Z-0065-2018 · Encore Medical, Lp · posted Nov 6, 2017 · Open, Classified
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
- Z-0066-2018 · Encore Medical, Lp · posted Nov 6, 2017 · Open, Classified
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
- Z-0067-2018 · Encore Medical, Lp · posted Nov 6, 2017 · Open, Classified
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
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.