STERILE SAMPLE BUILD — Class I medical device recall Z-1054-2014
Terminated recall by Medline Industries, Inc., reported 2014-03-05, distributed nationwide. Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The
| Recall number | Z-1054-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, Inc., Waukegan, IL, United States |
| Recall initiated | 2013-08-14 |
| Classified | 2014-02-21 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2017-12-19 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| Lot numbers | 13CD2146 |
| Model numbers | SAMP0147 |
Product
STERILE SAMPLE BUILD; REF: SAMP0147; 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1054-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.