Convatec EsteemBody Soft Convex recall
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h)…
Why was Convatec EsteemBody Soft Convex recalled?
Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, Lot Numbers 3L04674; h) 423657, UDI/DI 768455204069, Lot Numbers 3L04114; i) 423652, UDI/DI 768455204014, Lot Numbers 3L03669; j) 423646, UDI/DI 768455203956, Lot Numbers 3M01542; k) 423654, UDI/DI 768455204038, Lot Numbers 3M00021; l) 423653, UDI/DI 768455204021, Lot Numbers 3M00786; m) 423647, UDI/DI 768455203963, Lot Numbers 3M01540; n) 423644, UDI/DI 768455203932, Lot Numbers 3M01539; o) 423648, UDI/DI 768455203970, Lot Numbers 3M01541; p) 423665, UDI/DI 768455204144, Lot Numbers 3M00029; q) 423656, UDI/DI 768455204052, Lot Numbers 3L00958; r) 423651, UDI/DI 768455204007, Lot Numbers 3K03888; s) 423660, UDI/DI 768455204090, Lot Numbers 3M00022; t) 423661, UDI/DI 768455204106, Lot Numbers 3M00023
- 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)…
- Recalling firm
- ConvaTec, Inc
- Quantity
- 6709 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, UK.
- Recall date
- March 27, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)