Z-1088-04

SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD; CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG...

Name: Z-1088-04 SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD; CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG...
Creator: Thomas Medical Products Inc
Published: 2004-06-11
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2004-06-11 / Terminated

FDA source

Thomas Medical Products Inc began a recall of SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD; CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG (Coronary Sinus Guide)-2-09 Jumbo; CSG (Coronary Sinus... on 2004-06-11. The reason FDA records is "Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1088-04
Status: Terminated
Initiated: 2004-06-11
Posted: 2004-07-20
Terminated: 2005-06-27
Recalling firm: Merit Medical Systems, Inc.
Product: SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD; CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG (Coronary Sinus Guide)-2-09 Jumbo; CSG (Coronary Sinus Guide)/BCor/-2-09; CSG (Coronary Sinus Guide) Worley/L-1-09 Long; and CSG (Coronary Sinus Guide) Worley/L/BCor-1-09/Long.
Product code: DYB Introducer, Catheter
Reason for recall: Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
FDA root cause: Other
Action: The recalling firm send a recall letter via fax and Federal Express 6/11/2004 to the various wholesalers and/or distributors informing them of the recall and to return all product to the recalling firm.
Quantity in commerce: 39,605 kits
Distribution: The recall product was distributed to various distributors in the following states: CA and PA. There are no foreign or government accounts.
Product codes and lots: All lot numbers

Product code DYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)