Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1009. The product is shipped in cartons containing 5 units.

FDA Recall Z-0057-05 · Posted 2004-10-28

Recalling FirmThomas Medical Products Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2004-10-14
Date Terminated2006-01-24
Product Quantity805 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.

Official Source

View FDA Recall →

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

↑