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Recall Observatory FDA recall evidence

Device 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.

Z-1036-2019

January 09, 2019

Class II

Product summary

Firm
ConvaTec, Inc
Event
Event 82039
Status
Ongoing
Classification
Class II
Quantity
1,231,155 units total
Official record key
device-enforcement:Z-1036-2019

Official wording

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

Code information: Product Codes/REF Numbers: 417350, 417354; Lot Codes: 7D04313, 7E03449, 150723, 150957, 155792, 157603, 170833, 183854, 183855, 234561, 487048

Distribution pattern: 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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach in the sterile barrier