Z-1210-2019 Class I Terminated
FDA device recall Z-1210-2019 was initiated by Becton Dickinson & Company on February 28, 2019 and is designated Class I. Reason for recall: Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates. The recall status is terminated (terminated July 30, 2020). Affected quantity: 2900 Sets.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2019
- Initiation Date
- February 28, 2019
- Termination Date
- July 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2900 Sets
Product Description
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Reason for Recall
Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.
Distribution Pattern
US Nationwide Distribution in the states of AR, NH, NC
Code Information
Lot Number: 18046218 Exp. Date: 04/18/2021 UDI: 50885403234352