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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

ConvaTec, Inc: EsteemBody Soft Convex Drainable Pouches Recalled for Filter Weld Defects

Agency Publication Date: March 21, 2024
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Summary

Convatec Inc is recalling approximately 6,709 units of the EsteemBody Soft Convex, Drainable Pouch because the filter weld may be weak or inconsistent. This manufacturing defect can cause the pouch filter to fail or leak during use. The recall affects 20 different product variants sold worldwide, including in the United States. Consumers should check their ostomy supplies immediately for the affected product codes and lot numbers and contact their healthcare provider or the manufacturer for further instructions.

Risk

A weak filter weld can lead to leakage of the pouch contents or failure of the gas filter. This poses a risk of skin irritation, infection, or soilage for users who rely on these medical devices for ostomy care.

What You Should Do

  1. Identify if you have the affected products by checking for Product Codes (REF) 423643, 423658, 423659, 423664, 423666, 423645, 423667, 423657, 423652, 423646, 423654, 423653, 423647, 423644, 423648, 423665, 423656, 423651, 423660, and 423661.
  2. Check your specific lot numbers against the following list: 3L03391, 3L04005, 3L03670, 3L02230, 3L04004, 3L04989, 3L04674, 3L04114, 3L03669, 3M01542, 3M00021, 3M00786, 3M01540, 3M01539, 3M01541, 3M00029, 3L00958, 3K03888, 3M00022, and 3M00023.
  3. Verify the UDI/DI on the packaging, which includes numbers such as 768455203925, 768455204076, 768455204083, 768455204137, 768455204151, 976845520394, 768455204168, 768455204069, 768455204014, 768455203956, 768455204038, 768455204021, 768455203963, 768455203932, 768455203970, 768455204144, 768455204052, 768455204007, 768455204090, and 768455204106.
  4. Contact your healthcare provider or Convatec Inc directly for instructions on how to return affected pouches and to obtain replacements or a potential refund.
  5. For additional information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423643)
Model / REF:
423643
UPC Codes:
768455203925
Lot Numbers:
3L03391
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423658)
Model / REF:
423658
UPC Codes:
768455204076
Lot Numbers:
3L04005
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423659)
Model / REF:
423659
UPC Codes:
768455204083
Lot Numbers:
3L03670
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423664)
Model / REF:
423664
UPC Codes:
768455204137
Lot Numbers:
3L02230
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423666)
Model / REF:
423666
UPC Codes:
768455204151
Lot Numbers:
3L04004
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423645)
Model / REF:
423645
UPC Codes:
976845520394
Lot Numbers:
3L04989
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423667)
Model / REF:
423667
UPC Codes:
768455204168
Lot Numbers:
3L04674
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423657)
Model / REF:
423657
UPC Codes:
768455204069
Lot Numbers:
3L04114
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423652)
Model / REF:
423652
UPC Codes:
768455204014
Lot Numbers:
3L03669
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423646)
Model / REF:
423646
UPC Codes:
768455203956
Lot Numbers:
3M01542
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423654)
Model / REF:
423654
UPC Codes:
768455204038
Lot Numbers:
3M00021
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423653)
Model / REF:
423653
UPC Codes:
768455204021
Lot Numbers:
3M00786
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423647)
Model / REF:
423647
UPC Codes:
768455203963
Lot Numbers:
3M01540
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423644)
Model / REF:
423644
UPC Codes:
768455203932
Lot Numbers:
3M01539
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423648)
Model / REF:
423648
UPC Codes:
768455203970
Lot Numbers:
3M01541
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423665)
Model / REF:
423665
UPC Codes:
768455204144
Lot Numbers:
3M00029
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423656)
Model / REF:
423656
UPC Codes:
768455204052
Lot Numbers:
3L00958
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423651)
Model / REF:
423651
UPC Codes:
768455204007
Lot Numbers:
3K03888
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423660)
Model / REF:
423660
UPC Codes:
768455204090
Lot Numbers:
3M00022
Product: Convatec EsteemBody Soft Convex, Drainable Pouch (423661)
Model / REF:
423661
UPC Codes:
768455204106
Lot Numbers:
3M00023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94121
Status: Active
Manufacturer: ConvaTec, Inc
Manufactured In: United States
Units Affected: 6709 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.