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.
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-2896-2016
- Quantity
- 47989 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: 14015368 14056014 14056664 14105490 14106247 14115294 15035318 15046218 15065675 15066275 15095552 15097055 15105046
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.