Z-0025-2024 Class II Ongoing
FDA device recall Z-0025-2024 was initiated by Becton Dickinson Infusion Therapy Systems Inc. on August 29, 2023 and is designated Class II. Reason for recall: There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminat… The recall status is ongoing. Affected quantity: 98,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 11, 2023
- Initiation Date
- August 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98,000 units
Product Description
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Reason for Recall
There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.
Distribution Pattern
US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX.
Code Information
Lot # 2238464/ UDI-DI: (01)00382903868629