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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: B2-70071-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.

Z-2895-2016

July 29, 2016

Class II

Product summary

Firm
Zyno Medical LLC
Event
Event 74892
Status
Terminated
Classification
Class II
Quantity
78063 sets
Official record key
device-enforcement:Z-2895-2016

Official wording

Reason: Administration Set potential filter leaking

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

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Administration Set potential filter leaking