ConvaTec Recalls Feeding Tubes Due to Potential Sterile Barrier Breach
ConvaTec is recalling specific lots of Feeding Tube Metric devices because an internal assessment found a potential breach in the sterile barrier.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential sterile barrier breach, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ConvaTec, Inc. is recalling 1,231,155 units of Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. The affected products are labeled as xray CH05/40CM and xray CH08/40CM. These devices are intended for duodenal and stomach gastroenterology use to assist in drainage, decompression, or specimen collection, and to administer medication, fluids, or enteral feeding.
The recall was initiated after an internal assessment of the packaging confirmed the potential for a breach in the sterile barrier. The affected product codes are 417350 and 417354. The specific lot codes involved are 7D04313, 7E03449, 150723, 150957, 155792, 157603, 170833, 183854, 183855, 234561, and 487048.
The products were distributed worldwide, including in the United States (specifically IL, MI, PA, and WI) and numerous international locations. Consumers and healthcare providers should check their inventory for these specific lot and product codes and stop using the affected devices if they match the recalled lots.
The recalled product
- 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
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Feeding Tubes
- Affected units
- 1,231,155
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Product Codes/REF Numbers: 417350
- 417354
- Lot Codes: 7D04313
- 7E03449
- 150723
- 150957
- 155792
- 157603
- 170833
- 183854
- 183855
- 234561
- 487048
Distribution
Part of a larger recall action
This product is one of 4 recalled by ConvaTec, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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