FDA Device recall Z-1053-2014
STERILE SAMPLE CATH LAB PACK
- FDA Device
- Class I
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class I recall of STERILE SAMPLE CATH LAB PACK by Medline Industries, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1053-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-08-14 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Pack Number: SAMP0213; Lot: 13CD1774 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1053-2014%22
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