CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medlin

FDA device recall Z-1049-2014 · posted 2014-02-21 · Terminated

Recall details

Recalling firm

Medline Industries, Inc.

Reason for recall

Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.

Action taken

The firm, Medline Industries, Inc., sent a "RECALL IMMEDIATE ACTION REQUIRED" letter dated August 14, 2013, to its direct accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check their stocks for inventory of the affected products, quarantine any affected products, return the product using the enclosed shipping slips for credit-If additional stickers are needed, please call 866-359-1704, and complete and return the enclosed FAX-BACK VERIFICATION FORM listing the quantity of affected product(s) on hand via fax to Medline at 866-767-1290. If you have any questions, please contact 866-359-1704.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LRO

Quantity affected

120 units

Distribution

Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

Date initiated

2013-08-14

Date posted

2014-02-21

Date terminated

2017-12-19

Location

Waukegan, IL