Feeding Tube Metric — Class II medical device recall Z-1036-2019
Ongoing recall by ConvaTec, Inc, reported 2019-03-27, distributed nationwide. An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
| Recall number | Z-1036-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2019-01-09 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IL, IS, IT, KE, KR, KW, LB, NL, NO, NZ, PL, QA, SE, SG, SK, TR, VN, ZA |
| Quantity | 1,231,155 units |
| Reason classes | sterility |
| Lot numbers | 150723, 150957, 155792, 157603, 170833, 183854, 183855, 234561, 487048, 7D04313, 7E03449 |
| Model numbers | 417350, 417354 |
Product
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.
Reason for recall
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
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-1036-2019. 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.