Recall Z-2896-2016 ยท FPA Set, Administration, Intravascular
Zyno Medical LLC
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.
| Date | Sep 27, 2016 (initiated Jul 29, 2016) |
| Status | Terminated |
| Reason | Administration Set potential filter leaking |
| Root cause | Process control |
| Action | 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. |
| Quantity | 47989 sets |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132841 | ZYNO MEDICAL ADMINISTRATION SET Zyno Medical, LLC, Jan 23, 2014 |