Recall Z-2059-2019 ยท FPA Set, Administration, Intravascular
Zyno Medical LLC
Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F
| Date | May 29, 2019 |
| Status | Terminated |
| Reason | Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified |
| Root cause | Process control |
| Action | On May 29, 2019 Zyno issued letter to the Distributor advising of the problem and health risk and action to take: remove all recalled products with codes, cease use and immediately and return them to Zyno Medical for replacement from unaffected lots. Call or email for instructions on the return of products: (508) 907-7772 (Monday to Friday, 9:30 a.m. to 5 p.m. EST) or wagner.Cruz@zvnomed.com to acknowledge receiving this recall notice. Zyno issued a follow-up recall letter on 6/10/19 via email to the Distributor to issue to the user/customer level. |
| Quantity | 360 cases (50/case)=18,000 |
| Distribution | MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132841 | ZYNO MEDICAL ADMINISTRATION SET Zyno Medical, LLC, Jan 23, 2014 |