Z-1491-06

Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55...

Name: Z-1491-06 Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55...
Creator: Cobe Cardiovascular, Inc
Published: 2006-08-04
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2006-08-04 / Terminated / root cause: manufacturing process

FDA source

Cobe Cardiovascular, Inc began a recall of Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe... on 2006-08-04. The reason FDA records is "Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1491-06
Status: Terminated
Initiated: 2006-08-04
Posted: 2006-09-09
Terminated: 2011-12-28
Recalling firm: LivaNova USA, Inc.
Product: Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc.
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Consignees were notified by telephone and e-mail on 08/04/2006.
Quantity in commerce: 8,964 wash sets, 1,518 Stat pacs-Recalls Z-1488-1491-06
Distribution: Nationwide, including VA facilities in CA and OH
Product codes and lots: COBE Product Code-ASCBFE22, Lot numbers: 0610100225, 0613000077, 0615700007, 0618600109, 0621300094-- COBE Product Code-ASCBE22, Lot Numbers: 0608000247, 0610800007, 0612300036, 0613000076, 0613600146, 0615700006, 0617200003, 0617800128, 0619200116, 0619900053, 0621300093--COBE Product Code- AS9E55, Lot Numbers: 0617200004, 0619900054, 0621300095-COBE Product Code- AS9E22, Lot Numbers: 0611600047, 0612300034, 0613000075, 0614300116, 0617200002, 0617800127, 0618600107, 0621300092--COBE Product Code- AS9E12, Lot Numbers: 0612300035, 0615000022, 0616400011, 0618600108, 0619900052-COBE Product Code- AS4E55, Lot Numbers: 0616400012, 0618600110- COBE Product Code-AS4E22, Lot Numbers: 0609400006, 0610100223, 0615700005, 0619900051-COBE Product Code- AS4E17, Lot Numbers: 0613600145, 0616400013, 0617200005, 0619900055.

Product code CAC

K020647Class IIDideco ElectaDideco S.P.A. / cleared 2002-09-05

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)