Z-0543-2011

Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences...

Name: Z-0543-2011 Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences...
Creator: Edwards Lifesciences Llc
Published: 2010-10-19
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2010-10-19 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences Llc began a recall of Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614 on 2010-10-19. The reason FDA records is "Monitoring and Infusion Set connectors may break during manipulation". 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-0543-2011
Status: Terminated
Initiated: 2010-10-19
Posted: 2010-12-07
Terminated: 2011-05-18
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614.
Product code: DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Reason for recall: Monitoring and Infusion Set connectors may break during manipulation.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Edwards Lifesciences issued a Urgent Product Recall letter dated October 13, 2010 to customers identifying the affected devices, requesting the return of unused devices and completion and return of a response form. Further information is available at 800-424-3278.
Quantity in commerce: 570 sets
Distribution: Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR.
Product codes and lots: Lot No.: 58832055, 58896850, 58916757

Product code DTL

K892377Class IIRmi Aortic Root/coronary Sinus Monit./infusion SetResearch Medical, Inc. / cleared 1989-12-07

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)