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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: B2-70072-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-2896-2016

July 29, 2016

Class II

Product summary

Firm
Zyno Medical LLC
Event
Event 74892
Status
Terminated
Classification
Class II
Quantity
47989 sets
Official record key
device-enforcement:Z-2896-2016

Official wording

Reason: Administration Set potential filter leaking

Code information: Lot Code: 14015368 14056014 14056664 14105490 14106247 14115294 15035318 15046218 15065675 15066275 15095552 15097055 15105046

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Administration Set potential filter leaking