—#143296

Product

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 product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

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

Timeline

Recall initiated: 2016-01-20
Terminated: 2016-11-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143296. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.