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
This recall has been terminated (originally issued May 29, 2019).
- Company
- Zyno Medical Llc
- Recall Initiated
- May 29, 2019
- Terminated
- June 22, 2020
- Recall Number
- Z-2058-2019
- Quantity
- 354 cases (50/case)=17700
- Firm Location
- Natick, MA
- Official Source
- View on FDA website ↗
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
Distribution
MA
Lot / Code Info
Lot Numbers:18037128,18065375, 19015969 UDl/UPC/GTIN: 00814371020198
Root Cause
Process control
Action Taken
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.