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U.S. Department of Health and Human Services

Class 2 Device Recall Ponsky PEG

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 Class 2 Device Recall Ponsky PEGsee related information
Date Initiated by FirmDecember 04, 2008
Date PostedSeptember 15, 2009
Recall Status1 Terminated 3 on November 09, 2011
Recall NumberZ-2204-2009
Recall Event ID 50678
510(K)NumberK033562 K061021 K915841 K972025 K972101 
Product Classification Polypectomy snare for Percutaneous Endoscopic Gastrostomy - Product Code KNT
ProductBard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 003029, 20F, Sterile.
Code Information Lots: 43EQA085, 43FQA077, 43FQA177, 43GQA078, 43GQA079, 43GQA177,43GQA178, 43IQA091, 43IQA177, 43LQA109, HURA1456, HURB1687, HURB1688, HURB2446, HURB4538, HURD0616, HURD1300, HURD1993, HURE0754, HURE3446, HURF0571, HURH0035, HURH0293, HURH0685, HURH1221, HURI0670, HURJ0796, HURK1561, HUSA0503, HUSC0636, HUSD0279, HUSD2071, HUSF2001, HUSG0586. 
Recalling Firm/
Manufacturer		 C.R. Bard Access Systems, Inc
5425 Amelia Earhart Dr
Salt Lake City UT 84116-3713
For Additional Information Contact
801-595-0700
Manufacturer Reason
for Recall		Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBard contacted all 1,883 worldwide customers who received the distributed suspect 467 product code lots, comprising 177, 614 units that were either not expired or were still available in the field. These will be returned by the customer to Bard Access Systems. 1-800-290-1689.
Quantity in Commerce177,614 units
DistributionWorldwide, including USA, Belgium, Canada, Australia, and Japan.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = KNT
510(K)s with Product Code = KNT
510(K)s with Product Code = KNT
510(K)s with Product Code = KNT
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