FDA Medical Device Recalls (openFDA)
Abbott Vascular: Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac diagnostic or therapeutic procedures.
- Recall number
- Z-2791-2011
- Recalling firm
- Abbott Vascular
- Product
- Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac diagnostic or therapeutic procedures.
- Status
- Terminated
- Initiated
- 2011-01-07
- Posted
- 2011-07-12
- Terminated
- 2012-06-26
- Reason
- 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.
- Root cause
- Process control
- Action
- 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
- Quantity
- 389 units total
- Distribution
- Nationwide distribution, and Ireland.
- Lot, serial or model codes
- Lot Number: 0121091
- 510(k) numbers
- ["K950752"]
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 2024168
- Firm city
- Temecula
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28