PlainRecalls
FDA Devices Critical Class I Terminated

STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures..

Reported: March 5, 2014 Initiated: August 14, 2013 #Z-1052-2014

Product Description

STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures..

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.

Details

Recalling Firm
Medline Industries, Inc.
Units Affected
10 units
Distribution
Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures... Recalled by Medline Industries, Inc.. Units affected: 10 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 5, 2014. Severity: Critical. Recall number: Z-1052-2014.