Convatec EsteemBody Drainable Pouches Recalled for Filter Weld Defect
ConvaTec is recalling specific lots of EsteemBody Soft Convex Drainable Pouches due to inconsistency in filter weld strength, affecting 6709 units distributed in the US and internationally.
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: This is an FDA Class II recall of a medical device with a structural defect in filter weld strength. No illnesses or injuries have been reported in the source text. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ConvaTec, Inc is conducting a voluntary recall of specific lots of the EsteemBody Soft Convex Drainable Pouch due to inconsistency in the strength of the filter weld.
The affected medical device is an ostomy pouch for ostomy care. A total of 6709 units have been identified in this recall. The affected products were distributed worldwide, including throughout the United States, as well as in Italy and the United Kingdom.
Consumers who have the affected pouches should contact ConvaTec, Inc for guidance on the recall and to obtain information about replacement or return options.
The recalled product
- Product
- Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660,
- Manufacturer
- ConvaTec, Inc
- Hazard
- weld-defect
- filter-failure
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 (20)
- a) 423643
- UDI/DI 768455203925
- Lot Numbers 3L03391
- b) 423658
- UDI/DI 768455204076
- Lot Numbers 3L04005
- c) 423659
- UDI/DI 768455204083
- Lot Numbers 3L03670
- d) 423664
- UDI/DI 768455204137
- Lot Numbers 3L02230
- e) 423666
- UDI/DI 768455204151
- Lot Numbers 3L04004
- f) 423645
- UDI/DI 976845520394
- Lot Numbers 3L04989
- g) 423667
- UDI/DI 768455204168
Distribution
Distributed nationwide across the United States.
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