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Terminated

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

FDA Recall Z-0056-05 · Posted 2004-10-28

Recalling FirmThomas Medical Products Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2004-10-14
Date Terminated2006-01-24
Product Quantity1170 kits

Reason for Recall

Sheaths may fracture if exposed to excess fluorescent light

Firm 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.

Root Cause

Other

Distribution Pattern

The product was shipped to the label owner/distributor in CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K934901TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVEThomas Medical Products, Inc. · 1994-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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