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Terminated

Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices

FDA Recall Z-0865-2016 · Posted None

Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2016-01-20
Date Terminated2016-11-21
Product Quantity25

Reason for Recall

Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.

Firm Action

On 1/20/2016, URGENT: MEDICAL DEVICE RECALL notifications were sent to the hospital Risk Management/Recall Administration via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.

Official Source

View FDA Recall →

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

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