Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac diagnostic or therapeutic procedures.
FDA device recall Z-2791-2011 · posted 2011-07-12 · Terminated
Recall details
- Recalling firm
- Abbott Vascular
- Reason for recall
- Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization.
- Action taken
- Abbott Vascular sent an Urgent Device Recall letter, dated January 7, 2011, noting the products being recalled and the reasons for recall. The firm also provided the following reconciliation instructions to its territory manager: -Help customer identify aflected product. - CaIl Abbott Vascular Customer Service (800) 221-9902 to receive RGA number. Record RGA number below. - Fax this completed form to (951) 914-3826. - Return a copy of this completed form with the returned product
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 389 units total
- Distribution
- Nationwide distribution, and Ireland.
- Date initiated
- 2011-01-07
- Date posted
- 2011-07-12
- Date terminated
- 2012-06-26
- Location
- Temecula, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS (K950752) | Advanced Cardiovascular Systems, Inc. | 1995-05-15 |