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U.S. Department of Health and Human Services

Class 2 Device Recall Reusable Catheter Passer

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  Class 2 Device Recall Reusable Catheter Passer see related information
Date Initiated by Firm September 09, 2003
Date Posted November 27, 2003
Recall Status1 Terminated 3 on November 26, 2003
Recall Number Z-0160-04
Recall Event ID 27416
510(K)Number K853370  
Product Classification Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
Product Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle.
Code Information Catalog number SP01, Lot numbers H0359, J0107, and J0493.
Recalling Firm/
Manufacturer		 Vygon US LLC
2495 General Armstead Ave
Norristown PA 19403
For Additional Information Contact Courtney Smith
610-539-9300
Manufacturer Reason
for Recall		 mislabeled as sterile
FDA Determined
Cause 2		 Other
Action The recalling firm issued recall letters to their direct accounts via fax on 9/9/03. The letter informed the accounts of the problem and the need to sterilize the product or return it for replacements.
Quantity in Commerce 3 units
Distribution The products were shipped to one distributor in NY and two hospitals in TX and UT. The products were also shipped to distributors in Holland, Greece, Austria, Norway, Taiwan, and Finland.
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 = FOZ and Original Applicant = HOLTER-HAUSNER INTL.
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