FDA Recall Terminated

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.

Recall: Z-2893-2016 · Initiated July 29, 2016

Recall

Recall Number
Z-2893-2016
Event Number
74892
Firm
Zyno Medical LLC
FEI Number
3006575795
Product Code
FPA
Status
Terminated
Root Cause
Process control
Initiated
July 29, 2016
Posted
September 27, 2016
Terminated
July 11, 2017
Address
10 Tech Cir, Natick, MA, 01760-1029

Description

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.

Reason

Administration Set potential filter leaking

Action

Zyno issued Recall letter dated July 26th, 2016 to affected customers. Customers who received affected products were contacted between 7/29/2016 and 8/1/2016. Customers were asked to return unused product for replacement. For questions contact Customer Service Representative, at 508-907-7796, or [email protected]. Expanded Recall: Two recall letters issued on 11/3/2016 to address the newly identified lots. One letter for customers who received the initial recall letter and the other letter for newly affected customers who did not receive the initial recall letter.

Distribution

US Nationwide Distribution

Quantity

114081 sets