Date Initiated by Firm |
October 14, 2004 |
Date Posted |
October 28, 2004 |
Recall Status1 |
Terminated 3 on January 24, 2006 |
Recall Number |
Z-0056-05 |
Recall Event ID |
30242 |
510(K)Number |
K934901
|
Product Classification |
Introducer, Catheter - Product Code DYB
|
Product |
SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units |
Code Information |
Lot number F4910 exp 12/05, Lot number F5678 exp. 4/06, and Lot number F6251 exp. 6/06 |
Recalling Firm/ Manufacturer |
Thomas Medical Products Inc 65 Great Valley Pkwy Malvern PA 19355-1302
|
For Additional Information Contact |
Peter J. Rapp 610-296-3000
|
Manufacturer Reason for Recall |
Sheaths may fracture if exposed to excess fluorescent light
|
FDA Determined Cause 2 |
Other |
Action |
The recalling firm issued a letter to the distributor on 10/15/04 via fax and Federal Express. The letter informed them of the product and the need to return the product. The account was instructed to conduct a sub-recall. |
Quantity in Commerce |
1170 kits |
Distribution |
The product was shipped to the label owner/distributor in CA. |
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 = DYB and Original Applicant = THOMAS MEDICAL PRODUCTS, INC.
|