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.
This recall has been terminated (originally issued September 27, 2016).
- Company
- Zyno Medical Llc
- Recall Initiated
- July 29, 2016
- Posted
- September 27, 2016
- Terminated
- July 11, 2017
- Recall Number
- Z-2893-2016
- Quantity
- 114081 sets
- Firm Location
- Natick, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Administration Set potential filter leaking
Distribution
US Nationwide Distribution
Lot / Code Info
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
Root Cause
Process control
Action Taken
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 laryloring@zynomed.com. 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.