Z-0125-2021Class II

BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV...

Name: Z-0125-2021 BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV...
Creator: Becton Dickinson & Company
Published: 2020-09-14
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2020-09-14 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a... on 2020-09-14. FDA classified it as Class II and gives the reason as "Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0125-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-14
Posted: 2020-10-19
Terminated: 2021-09-27
Recalling firm: Becton Dickinson & Co
Product: BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens issued an "URGENT MEDICAL DEVICE RECALL" letter dated 9/14/20 to Distributors/Medical Facilities on 9/14/20 via FedX , email or faxed stating reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog (Ref) and Lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users within or outside your facility network to which you may have further distributed the affected product to ensure they are also aware of this recall. 3. 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. BD Customer/Technical Support, (844) 823-5433 Monday Friday between 8:30am and 5:00pm (EST) in the United States. For customers outside the US, contact your local BD representative or distributor.
Quantity in commerce: 12,020 units
Distribution: US: Nationwide Distribution: AK, AR, AZ, CA, IL, KS, MO, NY, OH, UT, VA; and International to: Canada and Mexico.
Product codes and lots: Lot Number: 9325212 UDI: 30382903835387

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0125-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0125-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-19

Product code FOZ

K183399Class IIBD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. / cleared 2019-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)