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

FDA device recall Z-0023-2011 · posted 2010-10-07 · Terminated

Recall details

Recalling firm

Becton Dickinson & Company

Reason for recall

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

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.

Root cause

Pending

Status

Terminated

Product code

GAA

Quantity affected

2,599,000 units

Distribution

Worldwide Distribution -- USA and Canada.

Date initiated

2010-08-24

Date posted

2010-10-07

Date terminated

2011-08-25

Location

Franklin Lakes, NJ