FDA Device Recall Z-0023-2011: Becton Dickinson & Company

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0023-2011.

Recall Res Number

Z-0023-2011

Recalling Firm / Manufacturer

Becton Dickinson & Company

FEI Number

2243072

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2010-08-24

Date Posted

2010-10-07

Date Terminated

2011-08-25

Product Code

GAA

Event Number

56663

Product Quantity

2,599,000 units

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

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

Action Details 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.

Distribution Pattern Worldwide Distribution -- USA and Canada.

Code Information / Serial Numbers Lot number 9057615

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Medical Device Recall: Z-0023-2011

Recall Parameters & Description

Related Establishments / Registrations

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