Z-0056-05

SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is...

Name: Z-0056-05 SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is...
Creator: Thomas Medical Products Inc
Published: 2004-10-14
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2004-10-14 / Terminated

FDA source

Thomas Medical Products Inc began a recall of SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units on 2004-10-14. The reason FDA records is "Sheaths may fracture if exposed to excess fluorescent light". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0056-05
Status: Terminated
Initiated: 2004-10-14
Posted: 2004-10-28
Terminated: 2006-01-24
Recalling firm: Merit Medical Systems, Inc.
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
Product code: DYB Introducer, Catheter
Reason for recall: Sheaths may fracture if exposed to excess fluorescent light
FDA root cause: Other
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.
Quantity in commerce: 1170 kits
Distribution: The product was shipped to the label owner/distributor in CA.
Product codes and lots: Lot number F4910 exp 12/05, Lot number F5678 exp. 4/06, and Lot number F6251 exp. 6/06

Product code DYB

K934901Class IITear-Away Sheath Introducer Set with Integral Hemostasis ValveThomas Medical Products, Inc. / cleared 1994-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)