Reported Mar 27, 2019 · Ongoing

Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM…

ConvaTec, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ConvaTec, Inc · 7900 Triad Center Dr Ste 400 · Greensboro, NC · 27409-9076

Is this the product you have?

  • Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit
  • Labeled asxray CH05/40CM
  • and xray CH08/40CM Product UsageDuodenal 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
Lot codes and dates
  • Product Codes/REF Numbers
    • 417350
    • 417354
  • Lot Codes
    • 7D04313
    • 7E03449
    • 150723
    • 150957
    • 155792
    • 157603
    • 170833
    • 183854
    • 183855
    • 234561
    • 487048
Amount recalled
1,231,155 units total

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:54 PM UTC

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