Z-1350-2024Class II

Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d)...

Name: Z-1350-2024 Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d)...
Creator: ConvaTec, Inc
Published: 2024-02-19
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2024-02-19 / Open, Classified / root cause: packaging

FDA source

ConvaTec, Inc began a recall of 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... on 2024-02-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1350-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-19
Posted: 2024-03-21
Recalling firm: ConvaTec Limited
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
Product code: FON Bag, Drainage, With Adhesive, Ostomy
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 6709 units
Distribution: Worldwide distribution - US Nationwide and the countries of Italy, UK.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1350-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1350-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-21

Product code FON

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)