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U.S. Department of Health and Human Services

Class 2 Device Recall Premicath 28G

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  Class 2 Device Recall Premicath 28G see related information
Date Initiated by Firm June 27, 2005
Date Posted October 28, 2005
Recall Status1 Terminated 3 on October 31, 2005
Recall Number Z-0090-06
Recall Event ID 32997
510(K)Number K041468  
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product Premicath 28G PICC Catheter
Code Information Lot numbers 014434 and 012615
Recalling Firm/
Manufacturer		 Vygon Corporation
2495 General Armistead Ave
Norristown PA 19403
For Additional Information Contact Courtney Smith
610-630-3350
Manufacturer Reason
for Recall		 Guidewire protuding from tip of the catheter
FDA Determined
Cause 2		 Other
Action The recalling firm issued a recall letter via fax to the distributors on 6/27/05. The letter informed the distributors of the problem and to notify any hospital accounts of the problem and the need to trim the catheter prior to implantation.
Quantity in Commerce 243 units
Distribution The product was shipped to distributors in CA, CO, FL, IL, MD, NJ, NY, OH, PA, TX and WA.
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.
510(K) Database 510(K)s with Product Code = LJS and Original Applicant = VYGON CORP.
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