Recall Z-1036-2019— ConvaTec, Inc
Class II · Ongoing
Class II FDA medical device recall by ConvaTec, Inc, initiated 2019-01-09. It names one FDA 510(k) clearance: K896734. 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..
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-01-09
- Firm location
- Greensboro, NC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.