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Terminated

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

FDA Recall Z-0023-2011 · Posted 2010-10-07

Recall StatusTerminated
Product CodeGAA
Date Initiated2010-08-24
Date Terminated2011-08-25
Product Quantity2,599,000 units

Reason for Recall

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

Firm 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.

Root Cause

Pending

Distribution Pattern

Worldwide Distribution -- USA and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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