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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 Medicalsee related information
Date Initiated by FirmJuly 29, 2016
Date PostedSeptember 27, 2016
Recall Status1 Terminated 3 on July 11, 2017
Recall NumberZ-2894-2016
Recall Event ID 74892
510(K)NumberK132841 
Product Classification Set, administration, intravascular - Product Code FPA
ProductZyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F 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 Lot Code: 14015257 14016574 14026116 14055563 14056558 14056578 14056564 14097009 14105233 14105981 14106122 14115694 14116060 14116061 15035164 15036531 15036532 15066217 15086619 15096764 15096765 15096843 15105499 
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
ActionZyno 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 Commerce78069 sets
DistributionUS Nationwide Distribution
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 = FPA
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