Recall Z-0025-2024— Becton Dickinson Infusion Therapy Systems Inc.
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson Infusion Therapy Systems Inc., initiated 2023-08-29. It names one FDA 510(k) clearance: K220584. 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. 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..
- Recalling firm
- Becton Dickinson Infusion Therapy Systems Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-29
- Firm location
- Sandy, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.