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U.S. Department of Health and Human Services

Class 2 Device Recall VenaFlow Sterile Calf Cuff

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 Class 2 Device Recall VenaFlow Sterile Calf Cuffsee related information
Date Initiated by FirmJanuary 17, 2019
Create DateJuly 18, 2019
Recall Status1 Open3, Classified
Recall NumberZ-1985-2019
Recall Event ID 82967
510(K)NumberK964238 
Product Classification Sleeve, limb, compressible - Product Code JOW
ProductAircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Code Information Lot # 418003 UDI: (01)00888912302418
FEI Number 2020737
Recalling Firm/
Manufacturer		 DJO, LLC
1430 Decision St
Vista CA 92081-8553
For Additional Information ContactDave Hunter
858-245-8747
Manufacturer Reason
for Recall		The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
FDA Determined
Cause 2		Environmental control
ActionOn January 18, 2019 a Urgent: Medical Device Recall letter was sent via email to customers. The letter ask all customers to send the notification to all customers who have purchased or were issued the affected product. In addition, the letter request that the customer complete the "Return Response" form by February 15, 2019. If you have any additional questions, please contact the firm at 1-800-321-9549.
Quantity in Commerce9 units
DistributionDistributed domestically, Oklahoma
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JOW
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