FDAClass IIJuly 31, 2019

Zyno Medical Administration Set -105"ADMIN SET 20DP recall

Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product…

Why was Zyno Medical Administration Set -105"ADMIN SET 20DP recalled?

Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers:18037128,18065375, 19015969 UDl/UPC/GTIN: 00814371020198

Product
Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product…
Recalling firm
Zyno Medical LLC
Quantity
354 cases (50/case)=17700
Distribution
MA
Recall date
July 31, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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