Device product
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
Z-2058-2019
Product summary
- Firm
- Zyno Medical LLC
- Event
- Event 83026
- Status
- Terminated
- Classification
- Class II
- Quantity
- 354 cases (50/case)=17700
- Official record key
device-enforcement:Z-2058-2019
Official wording
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
Code information: Lot Numbers:18037128,18065375, 19015969 UDl/UPC/GTIN: 00814371020198
Distribution pattern: MA
Derived failure modes
-
Unknown
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