Recalls / —
—#35785
Product
ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23.
- FDA product code
- FMF — Syringe, Piston
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K955235
- Affected lot / code info
- Batch # 4083690
Why it was recalled
Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).
Root cause (FDA determination)
Other
Action the firm took
BD has sent letters to the distributor McKesson Inc and the retailer Wal-Mart Inc.
Recalling firm
- Firm
- Becton Dickinson & Company
- Address
- 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2004-10-22
- Posted by FDA
- 2005-03-03
- Terminated
- 2006-04-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #35785. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.