SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1011. The product is shipped in
FDA device recall Z-0058-05 · posted 2004-10-28 · Terminated
Recall details
- Recalling firm
- Thomas Medical Products Inc
- Reason for recall
- Sheaths may fracture if exposed to excess fluorescent light
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 795 kits
- Distribution
- The product was shipped to the label owner/distributor in CA.
- Date initiated
- 2004-10-14
- Date posted
- 2004-10-28
- Date terminated
- 2006-01-24
- Location
- Malvern, PA
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