Recall Z-0023-2011

Becton Dickinson & Company · initiated August 24, 2010

Terminated

Product

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

Codes / lots: Lot number 9057615

Reason for recall

There have been reports of blocked/clogged needles for the 30 gauge PrecisionGlide Needles

FDA-determined cause: Pending

Action taken

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.

Details

Recall number
Z-0023-2011
Initiated
August 24, 2010
Posted by FDA
October 7, 2010
Terminated
August 25, 2011
Product code
GAA – Needle, Aspiration And Injection, Disposable
Quantity
2,599,000 units
Distribution
Worldwide Distribution -- USA and Canada.
Recalling firm
Becton Dickinson & Company, Franklin Lakes, NJ

Official FDA recall record