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Terminated

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

FDA Recall Z-2792-2011 · Posted 2011-07-12

Recalling FirmAbbott Vascular
Recall StatusTerminated
Product CodeDTL
Date Initiated2011-01-07
Date Terminated2012-06-26
Product Quantity389 units total

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.

Firm 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

Root Cause

Process control

Distribution Pattern

Nationwide distribution, and Ireland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991102COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331Guidant Corp. · 1999-06-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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