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

Is my product affected?

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

• UPC 00814371020204

Check against the official notice below — it lists the full affected range.

What happened

Zyno Medical LLC has recalled its Administration Set (Product Code B2-70072-F) designed for use with Zyno Medical infusion pumps or gravity feed systems. The recall affects 18,000 units (360 cases of 50 each) distributed in Massachusetts. The administration sets in certain lot numbers (18046309 and 18026344) were assembled with an inverted pinch clamp that can cause fluid to be pumped in the wrong direction when a secondary set is used with the primary set.

When the pinch clamp is inverted and not identified, the device may draw blood from the patient instead of delivering fluid to the patient, assuming space exists in the drug container. The recall notice does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: 360 cases (50/case)=18,000 Lot/code info: Lot Numbers: 18046309, 18026344 UDl/UPC/GTIN: 00814371020204

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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