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
Check against the official notice below — it lists the full affected range.
Zyno Medical LLC is recalling Zyno Medical Administration Sets (Product Code B2-70072) used with Zyno Medical infusion pumps or gravity feed systems. The recalled administration sets have an inverted pinch clamp that causes fluid to be pumped backward through the tubing when a secondary set is used with the primary set. This defect can result in blood being drawn from the patient instead of medication being delivered to the patient if there is space in the drug container. The recall affects 354 cases (17,700 units total) distributed in Massachusetts, specifically lot numbers 18037128, 18065375, and 19015969.
The recall applies to administration sets assembled with the inverted pinch clamp defect. The source document does not specify a remedy or corrective action for consumers who may have received affected products.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Quantity: 354 cases (50/case)=17700 Lot/code info: Lot Numbers:18037128,18065375, 19015969 UDl/UPC/GTIN: 00814371020198
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.