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Recall Observatory FDA recall evidence

Device product

BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536

Z-1710-2019

March 01, 2019

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 82330
Status
Terminated
Classification
Class II
Quantity
6,720 units
Official record key
device-enforcement:Z-1710-2019

Official wording

Reason: Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.

Code information: Lot Number: 8337721 Exp. 30-Nov-2021 UDI: 382903835362

Distribution pattern: US distribution to one distributor in VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.