FDA recall Z-2058-2019

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 Code:B2-70072

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

Distribution

MA

Key facts

Status

Terminated

Initiation date

2019-05-29

Report date

2019-07-31

Termination date

2020-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Natick, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2058-2019