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U.S. Department of Health and Human Services

Class 3 Device Recall Jet Medical 4F Single Lumen PICC Kit

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  Class 3 Device Recall Jet Medical 4F Single Lumen PICC Kit see related information
Date Initiated by Firm September 15, 2005
Date Posted October 28, 2005
Recall Status1 Terminated 3 on November 22, 2005
Recall Number Z-0104-06
Recall Event ID 33789
510(K)Number K003682  
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4
Code Information Lot number MABY950
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438-2936
For Additional Information Contact Susan Smith, RN
215-256-4201
Manufacturer Reason
for Recall		 The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F
FDA Determined
Cause 2		 Other
Action On 9/15/05, the recalling firm telephoned the two distributors to inform them of the problem and the need to return the product.
Quantity in Commerce 88 units
Distribution The products were shipped to distributors in OH and MO.
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 = MEDICAL COMPONENTS, INC.
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