Stryker Recalls Mislabeled VenaFlow Calf Compression Garments
Stryker is recalling 280 VenaFlow Calf Garments mislabeled as Pos-Lock Connectors in Texas due to labeling errors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 and involves a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Sustainability Solutions is recalling 280 units of the 3040-VenaFlow Calf Garment (Aircast) Quick Connect. These devices were mislabeled as 3010-PL Aircast Pos-Lock Connectors. The garments are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time on the calf.
The recall was initiated because the product was mislabeled with the wrong product code and name. The affected devices are identified by Lot 6285035 and UDI 00885825016661. The recall is classified as Class II by the FDA.
The affected devices were distributed to Texas. Consumers and healthcare providers should check their inventory for the 3040-VenaFlow Calf Garment with the specific lot number and UDI listed above. If found, the devices should be removed from use and returned to Stryker Sustainability Solutions according to their instructions.
The recalled product
- Product
- 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the…
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 280
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 (1)
- Lot 6285035. UDI: 00885825016661.
Distribution
Distributed in 1 state:
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