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U.S. Department of Health and Human Services

Class 2 Device Recall Zyno Medical

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  Class 2 Device Recall Zyno Medical see related information
Date Initiated by Firm July 29, 2016
Date Posted September 27, 2016
Recall Status1 Terminated 3 on July 11, 2017
Recall Number Z-2895-2016
Recall Event ID 74892
510(K)Number K132841  
Product Classification Set, administration, intravascular - Product Code FPA
Product Zyno Medical Administration Set, Sterile. RX
For Use with Zyno Medical Infusion Pumps or Gravity Feed
Product Code: B2-70071-DF
Product Code: B2-70071-DF-120 (expanded recall)

Product Usage:
Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.
Code Information B2-70071-DF Lot Codes: 14015279 14026620 14046841 14055191 14055786 14056225 14085743 14085742 15035297 15045941 15045940 15046600 15075275 15075835 15076761 15085107 15086621 15095200 15095647 15097179 15105595  B2-70071-DF-120 lot codes: 15066912 15075253 15075990 15076261 15076304 
Recalling Firm/
Manufacturer		 Zyno Medical LLC
10 Tech Cir
Natick MA 01760-1029
For Additional Information Contact
508-650-2008
Manufacturer Reason
for Recall		 Administration Set potential filter leaking
FDA Determined
Cause 2		 Process control
Action Zyno issued Recall letter dated July 26th, 2016 to affected customers. Customers who received affected products were contacted between 7/29/2016 and 8/1/2016. Customers were asked to return unused product for replacement. For questions contact Customer Service Representative, at 508-907-7796, or laryloring@zynomed.com. Expanded Recall: Two recall letters issued on 11/3/2016 to address the newly identified lots. One letter for customers who received the initial recall letter and the other letter for newly affected customers who did not receive the initial recall letter.
Quantity in Commerce 78063 sets
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FPA and Original Applicant = ZYNO MEDICAL LLC
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