BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away f
FDA device recall Z-0253-2007 · posted 2006-12-06 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.
- Action taken
- Recall notification was sent 9/8/06 to all direct accounts and distributors by US mail, return receipt requested. Consignees were asked to send product back to BD with the packing slip and shipping labels enclosed
- Root cause
- Other
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 1,744,400
- Distribution
- Worldwide, including USA, Canada, and Australia.
- Date initiated
- 2006-09-08
- Date posted
- 2006-12-06
- Date terminated
- 2007-05-08
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE (K991088) | Becton Dickinson Vacutainer Systems | 1999-05-28 |