ConvaTec, Inc: Medical Device Recall in 2019 - (Recall #: Z-1036-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 9, 2019

Date Posted: March 27, 2019

Recall Number: Z-1036-2019

Event ID: 82039

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1,231,155 units total

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.

Voluntary or Mandated:

Voluntary: Firm initiated