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U.S. Department of Health and Human Services

Class 2 Device Recall VenaFlow Calf Garment (Aircast)

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 Class 2 Device Recall VenaFlow Calf Garment (Aircast)see related information
Date Initiated by FirmDecember 01, 2017
Create DateDecember 21, 2017
Recall Status1 Terminated 3 on September 27, 2018
Recall NumberZ-0272-2018
Recall Event ID 78714
510(K)NumberK012403 
Product Classification Sleeve, limb, compressible - Product Code JOW
Product3040-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 Lot 6285035.  UDI: 00885825016661.
FEI Number 3009350690
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information Contact
888-763-8803
Manufacturer Reason
for Recall		3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
FDA Determined
Cause 2		Packaging
ActionAn 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.
Quantity in Commerce280 devices
DistributionDistributed to Texas.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = JOW
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