SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1009. The product is shipped in cartons containing 5 units.
This recall has been terminated (originally issued October 28, 2004).
- Company
- Thomas Medical Products Inc
- Recall Initiated
- October 14, 2004
- Posted
- October 28, 2004
- Terminated
- January 24, 2006
- Recall Number
- Z-0057-05
- Quantity
- 805 kits
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Sheaths may fracture if exposed to excess fluorescent light
Distribution
The product was shipped to the label owner/distributor in CA.
Lot / Code Info
Lot number F5861 exp. 6/06 and Lot number 6724 exp. 8/06
Root Cause
Other
Action Taken
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.
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