1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920 Intended use: Subcutaneous
FDA device recall Z-0174-2012 · posted 2011-11-07 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.
- Action taken
- The firm, BD, sent an "PRODUCT RECALL NOTIFICATION" letter and response form dated June 15, 2011 to their consignee/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately review their inventory for the affected product, remove the product from inventory, quarantine the product and return it to BD; if the product was further distributed, they should identify their customers and notify them at once, and complete and return the attached Tracking/Verification Form via fax to: 201-847-4853. If you have any questions, contact Customer Service at 1-800-237-2762, Monday -Thursday, 8:00am-6:30pm and on Friday, 8:00-5:30pm Eastern Standard Time.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KZH
- Quantity affected
- 10,230 shelf cartons (1,0230,000 syringes)
- Distribution
- Nationwide Distribution.
- Date initiated
- 2011-06-15
- Date posted
- 2011-11-07
- Date terminated
- 2015-07-27
- 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 INSULIN SYRINGE (K024112) | Becton, Dickinson & CO | 2003-01-09 |