FDA Medical Device Recalls (openFDA)
ConvaTec, Inc: 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
- Recall number
- Z-1350-2024
- Recalling firm
- ConvaTec, Inc
- 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, t) 423661
- Status
- Open, Classified
- Initiated
- 2024-02-19
- Posted
- 2024-03-21
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 6709 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, UK.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FON
- Firm FEI
- 3011987967
- Firm city
- Greensboro
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28