Z-2059-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2019
- Initiation Date
- May 29, 2019
- Termination Date
- June 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 360 cases (50/case)=18,000
Product Description
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
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 Pattern
MA
Code Information
Lot Numbers: 18046309, 18026344 UDl/UPC/GTIN: 00814371020204