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 calf.
Hazard
3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
What You Should Do
Remedy
An Urgent Medical Device Recall letter, dated December 5, 2017, was distributed to customers. The letter described the affected product and stated the reason for the recall, as well as the risk to health. Customers were instructed to discontinue use of the affected device ,and complete and return the recall effectiveness check form. All affected product should be returned per the instructions provided and a credit will be issued.
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Products
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
- Brand
- Stryker Sustainability Solutions
- UPC
- Lot 6285035. UDI: 00885825016661.
Units Affected
280 devices