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FDA device recall Z-1028-2016 · posted 2016-02-29 · Terminated

Recall details

Recalling firm

Cook Inc.

Reason for recall

Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids.

Action taken

Cook Medical sent an URGENT: MEDICAL DEVICE RECALL dated January 8, 2016, to all affected customers 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. Customers were instructed to do the following: Please review the attached list of affected products and lot numbers shipped to your account, and quarantine any affected product that remains unused. 2. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. 3. Please complete the attached Recall Response Form and return to Cook Medical either with the product or separately. 4. Please report any Adverse Event to Cook Medical Customer Relations 1-800- 457-4500 or 1-812-339-2235. Monday through Friday between 7:30 a.m. and 5:00 p.m. Eastern Daylight Time or email at FieldActionsNA@Cookmedical.com 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

Process control

Status

Terminated

Product code

MIJ

Quantity affected

134

Distribution

Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..

Date initiated

2016-01-08

Date posted

2016-02-29

Date terminated

2017-03-23

Location

Bloomington, IN