The Recall Desk
HighFDA (Devices)·Z-2059-2019·Announced 2019-07-31

Zyno Medical Administration Sets Recalled Due to Inverted Pinch Clamp Defect

Zyno Medical LLC is recalling administration sets where an inverted pinch clamp may cause blood to be drawn from the patient instead of delivering fluid.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that poses a risk of harm (blood withdrawal instead of fluid delivery) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Zyno Medical LLC is recalling Zyno Medical Administration Sets (Product Code: B2-70072-F) due to a manufacturing defect involving the pinch clamp. The recall affects 360 cases (18,000 units) distributed in Massachusetts. The specific lot numbers involved are 18046309 and 18026344.

The defect occurs when the pinch clamp is assembled in an inverted position. If a secondary set is used with the primary set, this configuration causes fluid from the distal end of the administration set to be pumped toward the proximal end. Consequently, instead of delivering medication to the patient, blood may be drawn from the patient if there is sufficient space in the drug container to hold the extra volume of fluid. This risk exists if the reversed pinch clamp is not identified by the user.

Healthcare providers and facilities should check their inventory for the affected product code and lot numbers. If the product is found, it should be removed from use and returned to Zyno Medical LLC in accordance with the recall instructions.

The recalled product

Product
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
Manufacturer
Zyno Medical LLC
Category
Medical Device — Infusion Pumps and Administration Sets
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Numbers: 18046309
  • 18026344 UDl/UPC/GTIN: 00814371020204

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Zyno Medical LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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