BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray
FDA device recall Z-0628-05 · posted 2005-03-18 · Terminated
Recall details
- Recalling firm
- Becton Dickinson Infusion Therapy
- Reason for recall
- Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
- Action taken
- Customers were contacted by telephone and by letters dated 01/10/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 15 units
- Distribution
- Domestic distribution: WI. International distribution: Puerto Rico, Virgin Islands. There were no military or VA facilities.
- Date initiated
- 2005-01-10
- Date posted
- 2005-03-18
- Date terminated
- 2005-04-12
- Location
- Sandy, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTA PERCUTANEOUS INTRODUCER SHEATH (K941428) | Ohmeda Medical | 1994-07-06 |