CLASS II Device recall · Reported 12 Jun 2019 · FDA Enforcement Report
BD Nexiva Dual Port -Closed IV Catheter System intended recalled
Becton Dickinson is recalling BD Nexiva Dual Port -Closed IV Catheter System intended for use in the peripheral, distributed in Virginia. The recall was initiated on 1 Mar 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1710-2019
- FDA event ID
- 82330
- Recalling firm
- Becton Dickinson, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Mar 2019
- FDA classified
- 3 Jun 2019
- Reported
- 12 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 1 Mar 2019 | Recall initiated by company | |
| 3 Jun 2019 | Classified by FDA | +94 days |
| 12 Jun 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
Where it was distributed
US distribution to one distributor in VA.
Questions about this recall
Why was it recalled?
Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
Which lots are affected?
Lot Number: 8337721 Exp. 30-Nov-2021 UDI: 382903835362
Where was it sold?
US distribution to one distributor in VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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