FDA Device

SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units

Hazard

Sheaths may fracture if exposed to excess fluorescent light

What You Should Do

Remedy

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.

Products

SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units
Brand
Thomas Medical Products Inc
UPC
Lot number F4910 exp 12/05, Lot number F5678 exp. 4/06, and Lot number F6251 exp. 6/06

Units Affected

1170 kits