Zyno Medical LLC: Medical Device Recall in 2019 - (Recall #: Z-2058-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.
Product Description:

Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072

Product Classification:

Class II

Date Initiated: May 29, 2019
Date Posted: July 31, 2019
Recall Number: Z-2058-2019
Event ID: 83026
Reason for Recall:

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

Status: Terminated
Product Quantity: 354 cases (50/case)=17700
Code Information:

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

Distribution Pattern:

MA

Voluntary or Mandated:

Voluntary: Firm initiated