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U.S. Department of Health and Human Services

Class 2 Device Recall Bard

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 Class 2 Device Recall Bardsee related information
Date Initiated by FirmAugust 04, 2003
Date PostedSeptember 11, 2003
Recall Status1 Terminated 3 on April 05, 2006
Recall NumberZ-1232-03
Recall Event ID 26909
510(K)NumberK980987 
Product Classification Syringe, Piston - Product Code FMF
ProductBard Ponsky PEG Safety System ''Pull'' Reoder Number: 001927
Code Information Lot Number: 43FNA088
Recalling Firm/
Manufacturer		 Bard Endoscopic Technologies
129 Concord Road
Building #3
Billerica MA 01821-7031
For Additional Information ContactBeth Zis
978-262-4866
Manufacturer Reason
for Recall		Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile
FDA Determined
Cause 2		Other
ActionBard Endoscopic notified customerson 8/4/03, by Recall Notice sent by registered mail, along with an Effectivity Form that each Bard account will complete and return. Product will be returned to Bard Endoscopic. 5. The BET Recall Coordinator will track effectivity, and phone accounts that have either not returned the Effectivity Form or whose letter had been returned as undeliverable.
Quantity in Commerce8 units
DistributionNationwide AZ, AL, CA, CO, CT, FL, GA, KY, IN, IL, KS, LA, MA, MD, MS, MN, MO, NH, NJ, NY, OH, MI, MO, PA, RI, TN, TX, VA, VT , WA Govt: VA MEDICAL CENTER/CC 800 HOSPITAL DR. COLUMBIA MO 06050
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 = FMF
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