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.
FDA Recall Z-0272-2018 · Posted None
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Recalling FirmStryker Sustainability Solutions
Recall StatusTerminated
Product CodeJOW
Date Initiated2017-12-01
Date Terminated2018-09-27
Product Quantity280 devices
Reason for Recall
3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
Firm Action
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.
Root Cause
Packaging
Distribution Pattern
Distributed to Texas.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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