Percutaneous Gastrojejunostomy Set Product Usage: Intended for the… — Class II medical device recall Z-0831-2018
Terminated recall by Cook Inc., reported 2018-03-07, distributed nationwide. Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire gu
| Recall number | Z-0831-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2017-10-19 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2019-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| Lot numbers | NS7587941 |
Product
Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Reason for recall
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
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-0831-2018. 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.