Z-2893-2016 Class II Terminated
FDA device recall Z-2893-2016 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: 114081 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
- 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