CLASS II ONGOING Device recall · Reported 27 Mar 2019 · FDA Enforcement Report
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit recalled
ConvaTec is recalling Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit, distributed nationwide in the US. The recall was initiated on 9 Jan 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1036-2019
- FDA event ID
- 82039
- Recalling firm
- ConvaTec, Greensboro, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jan 2019
- FDA classified
- 21 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 9 Jan 2019 | Recall initiated by company | |
| 21 Mar 2019 | Classified by FDA | +71 days |
| 27 Mar 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.
Questions about this recall
Why was it recalled?
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Which lots are affected?
Product Codes/REF Numbers: 417350, 417354; Lot Codes: 7D04313, 7E03449, 150723, 150957, 155792, 157603, 170833, 183854, 183855, 234561, 487048
Where was it sold?
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, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 82039This product is part of a recall event; the main page for the event is Nelaton Urinary Catheter, disposable, sterile recalled by ConvaTec.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Nelaton Urinary Catheter, disposable, sterile recalled by ConvaTec | ConvaTec | Sterility | Nationwide | |
| CLASS II | FilterFlow Suction Handle CH24, 20 eaches per sales unit recalled | ConvaTec | Sterility | Nationwide | |
| CLASS II | Forceps Blue, disposable, sterile, 100 eaches per sales unit recalled | ConvaTec | Sterility | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Esteem Body Soft Convex Urostomy recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | Aquacel Ag Surgical SP recalled by ConvaTec | ConvaTec | Potency & Assay | Nationwide |
| Device | CLASS II | EsteemBody Drainable recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | EsteemBody Drainable recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
| Device | CLASS II | EsteemBody Drainable recalled by ConvaTec | ConvaTec | Packaging Defects | Nationwide |
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| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |