Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-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.
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-2894-2016
- Quantity
- 78069 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
Lot Code: 14015257 14016574 14026116 14055563 14056558 14056578 14056564 14097009 14105233 14105981 14106122 14115694 14116060 14116061 15035164 15036531 15036532 15066217 15086619 15096764 15096765 15096843 15105499
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.