Z-2896-2016 Class II Terminated
FDA device recall Z-2896-2016 was initiated by Zyno Medical LLC on July 29, 2016 and is designated Class II. Reason for recall: Administration Set potential filter leaking The recall status is terminated (terminated July 11, 2017). Affected quantity: 47989 sets.
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
- 47989 sets
Product Description
Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F 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
Lot Code: 14015368 14056014 14056664 14105490 14106247 14115294 15035318 15046218 15065675 15066275 15095552 15097055 15105046