Teleflex MEDICAL WECK Visistat 35 — Class II medical device recall Z-1193-2018
Terminated recall by Teleflex Medical, reported 2018-04-04, distributed in KS. Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 indi
| Recall number | Z-1193-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2018-02-15 |
| Classified | 2018-03-26 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2018-10-31 |
| Distributed | KS |
| Quantity | 12 units |
| Reason classes | labeling |
| Lot numbers | 73H1600207 |
Product
Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
Reason for recall
Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.
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-1193-2018. 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.