Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072
FDA Recall Z-2058-2019 · Posted None
Recalling FirmZyno Medical LLC
Recall StatusTerminated
Product CodeFPA
Date Initiated2019-05-29
Date Terminated2020-06-22
Product Quantity354 cases (50/case)=17700
Reason for Recall
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
Firm 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 [email protected] 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.
Root Cause
Process control
Distribution Pattern
MA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.