Thomas Medical Products Inc Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG (Coronary Sinus Guide)/BCor-90/09. These sheaths packaged in 5 individual boxed kits per case carton. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG (Coronary Sinus Guide)/BCor-90/09. These sheaths packaged in 5 individual boxed kits per case carton.
Brand
Thomas Medical Products Inc
Lot Codes / Batch Numbers
All lot numbers are affected.
Products Sold
All lot numbers are affected.
Thomas Medical Products Inc is recalling Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG (Coronary Sinus Guide)/BCor-90/09. These sheaths due to Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN, OR, PA
Page updated: Jan 10, 2026