Z-2895-2016 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
78063 sets

Product Description

Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-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

B2-70071-DF Lot Codes: 14015279 14026620 14046841 14055191 14055786 14056225 14085743 14085742 15035297 15045941 15045940 15046600 15075275 15075835 15076761 15085107 15086621 15095200 15095647 15097179 15105595 B2-70071-DF-120 lot codes: 15066912 15075253 15075990 15076261 15076304