ConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
ConvaTec is recalling Esteem Body Soft Convex Urostomy Pouches because they may leak from the cap during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device defect (leakage) that poses a risk of harm to users, fitting the criteria for a High severity score where injury has not yet been reported.
Plain-English summary
ConvaTec, Inc. is recalling the Esteem Body Soft Convex Urostomy Pouches, including specific model and catalog numbers, due to a defect where the pouches may leak from the cap during use.
The recall involves 617,850 units distributed nationwide in the United States, including in the states of AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, and WA. The affected products are identified by specific UDI-DI and lot/serial numbers listed in the recall documentation.
Consumers should stop using the affected urostomy pouches and contact ConvaTec for a replacement or refund. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.
- Manufacturer
- ConvaTec, Inc
- Hazard
- Affected units
- 617,850
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Code: Product Name : Esteem Body" Urostomy Pouches UDI-DI: 00768455204526
- 00768455204533
- 00768455204540
- 00768455204564
- 00768455204571
- 00768455204588
- 00768455204595
- 00768455204618
- 00768455204625
- 00768455204632
- 00768455204649
- 00768455204656
- 00768455204663
- 00768455204670
- 00768455204700
- 00768455204717
- 00768455204724
- 00768455204748
- 00768455204755
- 00768455204762 Lot / Serial Numbers for US market : 5H0475
Distribution
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