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Recall Observatory FDA recall evidence

Device product

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

Z-0025-2024

August 29, 2023

Class II

Product summary

Firm
Becton Dickinson Infusion Therapy Systems Inc.
Event
Event 92970
Status
Ongoing
Classification
Class II
Quantity
98,000 units
Official record key
device-enforcement:Z-0025-2024

Official wording

Reason: 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.

Code information: Lot # 2238464/ UDI-DI: (01)00382903868629

Distribution pattern: US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.