Thomas Medical Products Inc SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Thomas Medical Products Inc
Lot Codes / Batch Numbers
Lot number F4910 exp 12/05, Lot number F5678 exp. 4/06, and Lot number F6251 exp. 6/06
Products Sold
Lot number F4910 exp 12/05, Lot number F5678 exp. 4/06, and Lot number F6251 exp. 6/06
Thomas Medical Products Inc is recalling SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The pr due to Sheaths may fracture if exposed to excess fluorescent light. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sheaths may fracture if exposed to excess fluorescent light
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN
Page updated: Jan 10, 2026