SafeSheath CSG (Coronary Sinus Guide) KR-90.09 and CSG (Coronary Sinus Guide) KR/BCor-90.09. These sheaths are packaged in 5 individual boxed kits per case carton.
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-1086-04
- 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 are affected.
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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