FDA Device recall Z-1036-2019
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit
- FDA Device
- Class II
- ongoing
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit by Convatec, citing an internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1036-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-01-09 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Convatec |
| Distribution | US |
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
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Identifiers
| code_info | Product Codes/REF Numbers: 417350, 417354; Lot Codes: 7D04313, 7E03449, 150723, 150957, 155792, 157603, 170833, 183854, 183855, 234561, 487048 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1036-2019%22
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