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U.S. Department of Health and Human Services

Class 2 Device Recall BD 30G1/2 PrecisionGlide Needle

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  Class 2 Device Recall BD 30G1/2 PrecisionGlide Needle see related information
Date Initiated by Firm August 24, 2010
Date Posted October 07, 2010
Recall Status1 Terminated 3 on August 25, 2011
Recall Number Z-0023-2011
Recall Event ID 56663
Product Classification Image-Intensified Fluoroscopic X-Ray System. - Product Code GAA
Product BD 30G1/2 PrecisionGlide¿ Needle;Catalog/Lot Number: 305106.

Needles are intended for use in aspiration and injection of medications.
Code Information Lot number 9057615
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Greg Morgan
201-847-4344
Manufacturer Reason
for Recall		 There have been reports of blocked/clogged needles for the 30 gauge PrecisionGlide Needles
FDA Determined
Cause 2		 Pending
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.
Quantity in Commerce 2,599,000 units
Distribution Worldwide Distribution -- USA and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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