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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: A2-80071-DF Product Code: A2-80071-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-2893-2016

July 29, 2016

Class II

Product summary

Firm
Zyno Medical LLC
Event
Event 74892
Status
Terminated
Classification
Class II
Quantity
114081 sets
Official record key
device-enforcement:Z-2893-2016

Official wording

Reason: Administration Set potential filter leaking

Code information: Product Code: A2-80071-DF Lot Code: 13125968 13126110 13126111 14026150 14055090 14056598 14065315 14065624 14067149 14075494 14085636 14105960 14106106 14106544 14116251 15045374 15045866 15046986 15055122 15055728 15067196 15085624 15085570 15086315 15086421 15086583 15105241 Product Code:A2-80071-DF-120 Lot code: 15085208

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Administration Set potential filter leaking