ConvaTec EsteemBody drainable pouch REF 423657 may leak
ConvaTec is recalling one lot of the EsteemBody Drainable Pouch, REF 423657, because the drainable large pouch may leak due to a manufacturing issue.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: an ostomy pouch that leaks exposes the wearer to its contents, and no injuries are stated in the source.
Plain-English summary
ConvaTec, Inc is recalling the Convatec EsteemBody Drainable Pouch, REF 423657, 10-35mm. The product was distributed worldwide, covering the United States nationwide and Australia, Canada, China, the Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, the Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland and the United Kingdom. The FDA has classified this recall as Class II.
The drainable large pouch may leak due to a manufacturing issue.
Affected product carries UDI 00768455221400 and lot 5J03908.
Users can identify affected pouches by the REF, UDI and lot number above, and may contact ConvaTec, Inc for further information.
The recalled product
- Product
- Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Ostomy care
- Hazard
- leakage
- manufacturing-defect
- skin-exposure
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 (1)
- UDI: 00768455221400/ Lot: 5J03908
Distribution
Distributed nationwide across the United States.
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