Recall Z-0023-2011 ยท GAA Needle, Aspiration And Injection, Disposable
Becton Dickinson & Company
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
| Date | Oct 7, 2010 (initiated Aug 24, 2010) |
| Status | Terminated |
| Reason | There have been reports of blocked/clogged needles for the 30 gauge PrecisionGlide Needles |
| Root cause | Pending |
| Action | BD sent out Product Correction letters to all end users of the product on 8/24/10. Letters were mailed by BD via UPS second day air. The letter stated the issue and said that customers should assess the patency prior to injection. The letter also stated that a BD 30 gauge PrecisionGlide Needle from another lot can be used in place of a clogged needle. If customers require replacement needles or further assistance, they can contact BD at 1-888-237-2762. Finally, the letter states that BD has implemented corrective actions to reduce the potential for further recurrence of the blockage issu |
| Quantity | 2,599,000 units |
| Distribution | Worldwide Distribution -- USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.