Medical Device
Manufacturing
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Z-0023-2011

BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and...

Becton Dickinson & Co / initiated 2010-08-24 / Terminated

Becton Dickinson & Company began a recall of BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications on . The reason FDA records is "There have been reports of blocked/clogged needles for the 30 gauge PrecisionGlide Needles". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0023-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Product code
GAA Needle, Aspiration And Injection, Disposable
Reason for recall
There have been reports of blocked/clogged needles for the 30 gauge PrecisionGlide Needles
FDA 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 issue.
Quantity in commerce
2,599,000 units
Distribution
Worldwide Distribution -- USA and Canada.
Product codes and lots
Lot number 9057615