ConvaTec, Inc. is recalling 1,715 units of the ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System. This recall was initiated because the kits contain a mismatched flange and pouch; the flange has a 45mm coupling ring, while the included pouch is designed for a larger 57mm ring. Because these two parts are different sizes, they cannot be securely connected, which could lead to product failure during use. Consumers should contact their healthcare provider or ConvaTec for further instructions regarding this mismatch.
The mismatch between the 45mm flange and the 57mm pouch prevents a secure connection between the ostomy components. This defect can lead to leakage of waste or the pouch becoming detached from the flange during use, potentially causing skin irritation or hygiene issues.
Contact healthcare provider or manufacturer
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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