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Recall Observatory FDA recall evidence

Device product

Zyno 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.

Z-2894-2016

July 29, 2016

Class II

Product summary

Firm
Zyno Medical LLC
Event
Event 74892
Status
Terminated
Classification
Class II
Quantity
78069 sets
Official record key
device-enforcement:Z-2894-2016

Official wording

Reason: Administration Set potential filter leaking

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

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Administration Set potential filter leaking