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.

Company: Stryker Sustainability Solutions
Recall Initiated: December 1, 2017
Terminated: September 27, 2018
Recall Number: Z-0272-2018
Quantity: 280 devices
Firm Location: Tempe, AZ

Reason for Recall

3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.

Distribution

Distributed to Texas.

Lot / Code Info

Lot 6285035. UDI: 00885825016661.

Root Cause

Packaging

Action Taken

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.