Z-2792-2011

Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac...

Name: Z-2792-2011 Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac...
Creator: Abbott Vascular
Published: 2011-01-07
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2011-01-07 / Terminated / root cause: manufacturing process

FDA source

Abbott Vascular began a recall of Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures on 2011-01-07. The reason FDA records is "Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging...". 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-2792-2011
Status: Terminated
Initiated: 2011-01-07
Posted: 2011-07-12
Terminated: 2012-06-26
Recalling firm: Abbott Vascular
Product: Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures.
Product code: DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Reason for recall: Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Abbott Vascular sent an Urgent Device Recall letter, dated January 7, 2011, noting the products being recalled and the reasons for recall. The firm also provided the following reconciliation instructions to its territory manager: -Help customer identify aflected product. - CaIl Abbott Vascular Customer Service (800) 221-9902 to receive RGA number. Record RGA number below. - Fax this completed form to (951) 914-3826. - Return a copy of this completed form with the returned product
Quantity in commerce: 389 units total
Distribution: Nationwide distribution, and Ireland.
Product codes and lots: Lot Number: 0121191

Product code DTL

K991102Class IICopilot Bleedback Control Valve, Model 1003331Guidant Corp. / cleared 1999-06-09

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)