Recall Z-1036-2019 ยท FPD Tube, Feeding
ConvaTec, Inc
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 obt
| Date | Jan 9, 2019 |
| Status | Open, Classified |
| Reason | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. |
| Root cause | Package design/selection |
| Action | ConvaTec notified customers on about 01/09/2019 via "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter. Instructions included how to identify affected product on the primary packaging and/or shipping carton as well as specific instructions for distributors, retailers, and end users (hospitals, EMT services, others). Distributors were instructed to inspect their inventory for affected products, perform a count of affected product in inventory, complete and return the response form, contact Customer Service at 1-800-582-6514 or ushcreturns@ups.com to report affected inventory on hand, forward |
| Quantity | 1,231,155 units total |
| Distribution | Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kenya, K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K896734 | FEEDING TUBE Unoplast A/S, Dec 21, 1990 |