FDA Medical Device Recalls (openFDA)
Cobe Cardiovascular, Inc: ASY, Brat Pack Procedure Set
- Recall number
- Z-1072-05
- Recalling firm
- Cobe Cardiovascular, Inc
- Product
- ASY, Brat Pack Procedure Set
- Status
- Terminated
- Initiated
- 2005-06-22
- Posted
- 2005-08-03
- Terminated
- 2006-07-27
- Reason
- Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
- Root cause
- Other
- Action
- Domestic customers were notified by overnight letter beginning 6/22/2005.Foreign consignees were notified by e-mail on 6/16-17/2005
- Quantity
- 2912 units
- Distribution
- Nationwide, including VA facilities in PA and WA. No other military or government consignees. Foreign distribution to Australia, Canada, Italy and Japan.
- Lot, serial or model codes
- Catalog Number: 007214102. Lot numbers 0511600006, 0512300005, 0513000006, 0513700007, 0513700005, 0514400007, 0514400008, 0515100189
- 510(k) numbers
- ["K933625"]
- PMA numbers
- not on file
- Product code
- CAC
- Firm FEI
- 1718850
- Firm city
- Arvada
- Firm state
- CO
- 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