Z-0265-06

Custom heart lung perfusion packs

Name: Z-0265-06 Custom heart lung perfusion packs
Creator: Cobe Cardiovascular, Inc
Published: 2005-10-06
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2005-10-06 / Terminated

FDA source

Cobe Cardiovascular, Inc began a recall of Custom heart lung perfusion packs on 2005-10-06. The reason FDA records is "One way valve in the heart lung pack assembly may be missing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0265-06
Status: Terminated
Initiated: 2005-10-06
Posted: 2005-12-02
Terminated: 2011-08-05
Recalling firm: LivaNova USA, Inc.
Product: Custom heart lung perfusion packs
Product code: DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Reason for recall: One way valve in the heart lung pack assembly may be missing.
FDA root cause: Other
Action: Consignees notified by letter on 10/06/2005.
Quantity in commerce: 21,512 units
Distribution: Nation wide, including VA facilities in FL, NM, & CO and military facilities in CA, VA, & WA.
Product codes and lots: 210 unique catalog numbers with 779 unique lot numbers.

Product code DTM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)