# China NMPA Product Recall - Hydrocolloid Dressing DuoDERM CGF Control Gel Formula Border Dressing

Source: https://www.globalkeysolutions.net/records/china_product_recall/convatec-inc/1109d194-6550-48c7-8c62-3059e04f1bae/
Source feed: China

> China NMPA product recall for Hydrocolloid Dressing DuoDERM CGF Control Gel Formula Border Dressing by ConvaTec Inc. published September 18, 2021. Recall level: . ConvaTec Inc., in collaboration with ConvaTec (China) Medical Supplies Co., Ltd., has initiated a vo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: ConvaTec Inc. is voluntarily recalling its hydrocolloid dressing, DuoDERM CGF Control Gel Formula Border Dressing.
- Company Name: ConvaTec Inc.
- Publication Date: 2021-09-18
- Product Name: Hydrocolloid Dressing DuoDERM CGF Control Gel Formula Border Dressing
- Recall Reason: The product's inner packaging may contain the wrong product; that is, the inner packaging should be a square dressing instead of a teardrop shape.
- Discovering Company: Convide (China) Medical Supplies Co., Ltd.
- Manufacturing Company: ConvaTec Inc.
- Summary: ConvaTec Inc., in collaboration with ConvaTec (China) Medical Supplies Co., Ltd., has initiated a voluntary recall for specific batches of its DuoDERM CGF Control Gel Formula Border Dressing. This action was officially reported on September 18, 2021, under the regulatory oversight of the National Medical Products Administration (NMPA).

The primary issue prompting this recall is a manufacturing error concerning product packaging. It was identified that the inner packaging of certain product models and batches may contain an incorrect item; specifically, the inner packaging, which should contain a teardrop-shaped dressing, was found to incorrectly hold a square dressing. This packaging discrepancy represents a significant product mix-up within sealed units, posing a risk of the wrong product being used by consumers or healthcare professionals.

While this recall was not triggered by specific inspection dates, it is a proactive measure undertaken by ConvaTec to address the identified quality control issue. The required action involves the immediate voluntary recall of all affected DuoDERM CGF Control Gel Formula Border Dressing products. Detailed information regarding the specific models, specifications, and batch numbers of the products involved, as well as the recall level, is provided in the official "Medical Device Recall Event Report Form." This action ensures regulatory compliance and aims to mitigate any potential patient safety concerns arising from the packaging error.

Company: https://www.globalkeysolutions.net/companies/convatec-inc/8059b175-8606-43d1-9058-ff38e7324229/