Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general indications, treatment of supra
FDA device recall Z-1617-2008 · posted 2008-08-30 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Package sterile barrier may be breached, compromising sterility.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DRF
- Quantity affected
- 827 units total
- Distribution
- Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.
- Date initiated
- 2008-02-14
- Date posted
- 2008-08-30
- Date terminated
- 2011-01-08
- Location
- San Jose, CA
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