Recall Z-1865-2017 ยท OKV Obstetrical Kit
Avid Medical, Inc.
Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.
| Date | Apr 19, 2017 (initiated Mar 15, 2017) |
| Status | Terminated |
| Reason | Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer component 519700 (BD: 367863) expiring 12/16 was discovered inside of a kit labelled with an expiration date after 12/16. Upon receipt of complaint, AVID Medical promptly initiated an internal investigation and root cause analysis. Investigation found mixed component lots were contained in product 519700 component case. This occurrence resulted in the incorrect lot number and expiration being attributed to all work orders produced using the affected component. This issue was immediately contained |
| Root cause | Employee error |
| Action | Avid Medical has identified all impacted products along with distribution centers and end-users as addressed in the tables supplied within this notification. An urgent medical device notice of correction will be issued to alert end-users about the inaccurate expiration date on convenience kits containing the vacutainer component(s) (See attachment). A correction response form will be used to effectively manage all distributer/end-user confirmation of required actions (See attachment). Avid Medical will make three attempts to confirm appropriate actions have been taken and acknowledged by eac |
| Quantity | 25308 |
| Distribution | All products are distributed through distribution centers confined to the US. All end-users for these products are also solely located in the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.