Z-1070-05

ASY, Brat 2 Pack Procedure Set

Name: Z-1070-05 ASY, Brat 2 Pack Procedure Set
Creator: Cobe Cardiovascular, Inc
Published: 2005-06-22
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2005-06-22 / Terminated / root cause: packaging

FDA source

Cobe Cardiovascular, Inc began a recall of ASY, Brat 2 Pack Procedure Set on 2005-06-22. The reason FDA records is "Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1070-05
Status: Terminated
Initiated: 2005-06-22
Posted: 2005-08-03
Terminated: 2006-07-27
Recalling firm: LivaNova USA, Inc.
Product: ASY, Brat 2 Pack Procedure Set
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
Root cause tag: packaging
FDA 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 in commerce: 1120 units
Distribution: Nationwide, including VA facilities in PA and WA. No other military or government consignees. Foreign distribution to Australia, Canada, Italy and Japan.
Product codes and lots: Catalog Number: 007213102. Lot numbers 0511600004, 0512300004, 0513000005, 0513700004, 0514400006.

Product code CAC

K933625Class IIBrat 2 Autologus Blood Salvage SystemCobe Cardiovascular, Inc. / cleared 1993-12-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)