ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23.
FDA device recall Z-0569-05 · posted 2005-03-03 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).
- Action taken
- BD has sent letters to the distributor McKesson Inc and the retailer Wal-Mart Inc.
- Root cause
- Other
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 1543000 syringes
- Distribution
- The syringes were sent to McKesson Corp, 120 Senlac Drive, Carrollton, TX 75006 who then sold them to Wal-Mart Corp, 702 SW 8th Street, Bentonville, AR 72716. There are no other customers.
- Date initiated
- 2004-10-22
- Date posted
- 2005-03-03
- Date terminated
- 2006-04-14
- 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 |
|---|---|---|
| B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE (K955235) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1996-02-12 |