Z-1053-2014 Class I Terminated
FDA device recall Z-1053-2014 was initiated by Medline Industries, Inc. on Aug 14, 2013 and is designated Class I. 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… The recall status is terminated (terminated Dec 19, 2017). Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 5, 2014
- Initiation Date
- Aug 14, 2013
- Termination Date
- Dec 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; 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.
Distribution Pattern
Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.
Code Information
Pack Number: SAMP0213; Lot: 13CD1774
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1053-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026