Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter
This recall has been terminated (originally issued August 30, 2008).
- Company
- Boston Scientific Corp
- Recall Initiated
- February 14, 2008
- Posted
- August 30, 2008
- Terminated
- January 8, 2011
- Recall Number
- Z-1618-2008
- Quantity
- 827 units total
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Package sterile barrier may be breached, compromising sterility.
Distribution
Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.
Lot / Code Info
Model Numbers M0042027BL0 (Lot#: 0011092878, 0011092882, 0011107097) and M0042028BL0 (Lot#: 0011036506, 0011036507, 0011036585, 0011036586, 0011043535, 0011043537, 0011046910, 0011046913, 0011049772, 0011049773, 0011054879, 0011055000, 0011059409, 0011059410, 0011061991, 0011061992, 0011065023, 0011065024, 0011069509, 0011069510, 0011073729, 0011073730, 0011078604, 0011078605, 0011081318, 0011081445, 0011083742, 0011083743, 0011087354, 0011087355, 0011088108, 0011088109, 0011096360)
Root Cause
Nonconforming Material/Component
Action Taken
Recall initiated on Feb. 14, 2008, via Urgent Medical Device Recall notification being sent to consignees, along with a reply verification tracking form. If you have questions or need a copy of the recall notification, contact Deborah J. Springer at 1-408-935-4944 or springed@bsci.com.