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.
Action Details
On August 29, 2023, Becton Dickinson issued an "Urgent Medical Device Recall" notification via. FedEx. Becton Dickinson asked consignees to take the following actions:
1. Immediately review your inventory for Catalog Number 386862, Lot number 2238464.
Destroy all unused product subject to the recall following your institution's process for
destruction.
2. For indwelling catheters, no further action is needed.
3. If a defective product was used on a patient and the used needle was disposed of
without the clinician suffering a needlestick injury, no further action is necessary to
further protect the patient or the clinician.
4. Share this recall notification with all users within your facility network of the product to
ensure they are also aware of this recall.
5. Complete the attached Customer Response Form and return to the BD contact noted
on the form whether or not you have any of the impacted material so that BD may
acknowledge your receipt of this notification per FDA requirements and subsequently
process your product replacement.
6. Report any adverse health consequences experienced with the use of this product to
BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting
program via: Web: MedWatch website at www.fda.gov/medwatch, Phone: 1-800-FDA 1088 (1-800-332-1088), Mail: MedWatch, HF-2, FDA, 5600 Fisher.s Lane, Rockville, MD 20852-978
Distribution Pattern
US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX.
Code Information / Serial Numbers
Lot # 2238464/ UDI-DI: (01)00382903868629
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.