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3040-VenaFlow Calf Garment (Aircast) Quick Connect was… recallZ-0272-2018 · Stryker Sustainability Solutions · initiated Dec 1, 2017

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Sustainability Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging

What the company is doing

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.

Recall details

Recall number
Z-0272-2018
Status
Terminated
Initiated by the company
Dec 1, 2017
Recalling firm
Stryker Sustainability Solutions
Quantity
280 devices
Product code
JOW
FDA submissions
K012403
Distribution
Distributed to Texas.

Product description

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.

Code information (models, lots, serial numbers)

Lot 6285035.  UDI: 00885825016661.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page