ESTEEM recallZ-1350-2024 · ConvaTec, Inc · initiated Feb 19, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ConvaTec, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
ConvaTec issued an URGENT: VOLUNTARY MEDICAL DEVICE RECALL notice to its consignees on 02/19/2024 via email. The notice explained the problem and requested the consignee quarantine the affected product and respond. Upon receipt, the firm will issue a Certificate of destruction and request the destruction of the product. The notice be shared with the correct individual with the organization and disseminated to all who need to be aware and distributors were directed to notify their customers.
Recall details
- Recall number
- Z-1350-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 19, 2024
- Posted by the FDA
- Mar 21, 2024
- Recalling firm
- ConvaTec, Inc
- Quantity
- 6709 units
- Product code
- FON
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, UK.
Product description
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, t) 423661
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
19 devices in the FDA device registry whose identifier appears in the recall's code information.
- ESTEEM 423643Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423653Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423657Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423646Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall1 report
- ESTEEM 423665Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall1 report
- ESTEEM 423644Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423647Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423648Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423651Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423652Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423654Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423656Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423658Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423659Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423660Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423661Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423664Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423666Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423667Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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