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Class 2 Device Recall Bard |
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Date Initiated by Firm |
August 04, 2003 |
Date Posted |
September 11, 2003 |
Recall Status1 |
Terminated 3 on April 05, 2006 |
Recall Number |
Z-1232-03 |
Recall Event ID |
26909 |
510(K)Number |
K980987
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Product Classification |
Syringe, Piston - Product Code FMF
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Product |
Bard 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
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For Additional Information Contact |
Beth Zis 978-262-4866
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Manufacturer Reason for Recall |
Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile
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FDA Determined Cause 2 |
Other |
Action |
Bard 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 Commerce |
8 units |
Distribution |
Nationwide
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
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Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = FMF and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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