Z-2893-2016 Class II Terminated

Recalled by Zyno Medical LLC — Natick, MA

Recall Details

Product Type
Devices
Report Date
October 5, 2016
Initiation Date
July 29, 2016
Termination Date
July 11, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
114081 sets

Product 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 for Recall

Administration Set potential filter leaking

Distribution Pattern

US Nationwide Distribution

Code Information

Product Code: A2-80071-DF Lot Code: 13125968 13126110 13126111 14026150 14055090 14056598 14065315 14065624 14067149 14075494 14085636 14105960 14106106 14106544 14116251 15045374 15045866 15046986 15055122 15055728 15067196 15085624 15085570 15086315 15086421 15086583 15105241 Product Code:A2-80071-DF-120 Lot code: 15085208