PlainRecalls
FDA Devices Moderate Class II Terminated

Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F

Reported: July 31, 2019 Initiated: May 29, 2019 #Z-2059-2019

Product Description

Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F

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

Details

Recalling Firm
Zyno Medical LLC
Units Affected
360 cases (50/case)=18,000
Distribution
MA
Location
Natick, MA

Frequently Asked Questions

What product was recalled?
Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F. Recalled by Zyno Medical LLC. Units affected: 360 cases (50/case)=18,000.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Devices on July 31, 2019. Severity: Moderate. Recall number: Z-2059-2019.