ClearanceBrief
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.

DateOct 7, 2010 (initiated Aug 24, 2010)
StatusTerminated
ReasonThere have been reports of blocked/clogged needles for the 30 gauge PrecisionGlide Needles
Root causePending
ActionBD 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
Quantity2,599,000 units
DistributionWorldwide Distribution -- USA and Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.