[pending] Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Pending LLM rewrite. Source: FDA_DEVICE Z-1583-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Drainable large pouch may leak due to manufacturing issue.
The recalled product
- Product
- Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Devices
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: 00768455221363 Lot: 5K01728
Distribution
Distributed nationwide across the United States.
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