BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile REF 368656
FDA device recall Z-0034-2007 · posted 2006-10-12 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have pre-activated or have defects affecting package integrity.
- Action taken
- Recall notification were mailed out first class mail, return receipt requested, approximately 8/24/2006 to distributors, who were then asked to contact their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 110,300 units
- Distribution
- Nationwide.
- Date initiated
- 2006-08-11
- Date posted
- 2006-10-12
- 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 |
|---|---|---|
| BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET (K011984) | Becton, Dickinson & CO | 2001-08-29 |