Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG (Coronary Sinus Guide)/BCor-90/09. These sheaths packaged in 5 individ
FDA device recall Z-1085-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Thomas Medical Products Inc
- Reason for recall
- Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 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.
- Date initiated
- 2004-06-11
- Date posted
- 2004-07-20
- Date terminated
- 2005-06-27
- Location
- Malvern, PA
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