FDA Device Recalls

Recalls /

#94201

Product

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

FDA product code
GAANeedle, Aspiration And Injection, Disposable
Device class
Class 1
Medical specialty
General, Plastic Surgery
Affected lot / code info
Lot number 9057615

Why it was recalled

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

Root cause (FDA determination)

Pending

Action the firm took

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.

Recalling firm

Firm
Becton Dickinson & Company
Address
1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern
Worldwide Distribution -- USA and Canada.

Timeline

Recall initiated
2010-08-24
Posted by FDA
2010-10-07
Terminated
2011-08-25
Status

Source: openFDA Device Recall endpoint. Recall record ID #94201. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.