ConvaTec Recalls FilterFlow Suction Handles Due to Sterile Barrier Breach Risk
ConvaTec is recalling 124,000 FilterFlow Suction Handles because an internal assessment found a potential breach in the sterile barrier.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a 'potential' breach in the sterile barrier based on an internal assessment, with no reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ConvaTec, Inc. is recalling 124,000 units of FilterFlow Suction Handle CH24. The device is designed for orthopedic surgery to remove and collect debris and bone fragments while combining suctioning with filtering. The recall was initiated after an internal assessment of the packaging confirmed the potential for a breach in the sterile barrier.
The affected products are identified by Product Code/REF Number 504159 and Lot Codes 176482 and 189027. Each sales unit contains 20 handles. The products were distributed worldwide, including in the United States (Illinois, Michigan, Pennsylvania, and Wisconsin) and numerous international locations such as Australia, Canada, the United Kingdom, and various European and Asian countries.
Healthcare providers and facilities should stop using the recalled devices and contact ConvaTec for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments,
- Manufacturer
- ConvaTec, Inc
- Hazard
- Affected units
- 124,000
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 (3)
- Product Code/REF Number: 504159
- Lot Codes: 176482
- 189027
Distribution
Part of a larger recall action
This product is one of 4 recalled by ConvaTec, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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