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.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Thomas Medical Products Inc
- Recall Initiated
- June 11, 2004
- Posted
- July 20, 2004
- Terminated
- June 27, 2005
- Recall Number
- Z-1088-04
- Quantity
- 39,605 kits
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
Distribution
The recall product was distributed to various distributors in the following states: CA and PA. There are no foreign or government accounts.
Lot / Code Info
All lot numbers
Root Cause
Other
Action Taken
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.
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