Date Initiated by Firm | April 11, 2008 |
Date Posted | September 16, 2008 |
Recall Status1 |
Terminated 3 on October 28, 2008 |
Recall Number | Z-1910-2008 |
Recall Event ID |
47856 |
510(K)Number | K053345 |
Product Classification |
Long term greater than 30 days therapeutic Intravascular Catheter - Product Code LJS
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Product | USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units per box and is indicated for short and long term access to the central venous system. |
Code Information |
Lot number MAPA880 |
Recalling Firm/ Manufacturer |
Medical Components, Inc dba MedComp 1499 Delp Dr Harleysville PA 19438-2936
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For Additional Information Contact | Susan Smith, RN BSN 215-256-4201 |
Manufacturer Reason for Recall | kit contains incorrect component |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product. |
Quantity in Commerce | 250 units |
Distribution | The products were shipped to customers in PA and TX. |
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 = LJS
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