Z-0091-2023Class II

Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a...

Name: Z-0091-2023 Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a...
Creator: B. Braun Medical, Inc.
Published: 2022-09-15
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2022-09-15 / Open, Classified / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or... on 2022-09-15. FDA classified it as Class II and gives the reason as "The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0091-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-15
Posted: 2022-10-14
Recalling firm: B Braun Medical Inc
Product: Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.
Product code: FPA Set, Administration, Intravascular
Reason for recall: The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On September 15, 2022, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were instructed to cease use and quarantine the product subject to recall. Once customers have returned the completed acknowledgement form to B. Braun Medical Inc., a Customer Support representative will contact the customer with instructions on returning impacted cases. The firm will provide credit and/or replacement of the product based on the customer's needs. For questions, please contact BBMI's Postmarket Surveillance Department at 1-833-425-1464.
Quantity in commerce: 354,200 US; 1,800 OUS
Distribution: Distribution US nationwide, Canada and Saudi Arabia.
Product codes and lots: UDI-DI (GTIN): 04046964540943 Lots/Expiration Dates 61705083 31-Oct-22 61705124 31-Oct-22 61706055 31-Oct-22 61714103 31-Dec-22 61719696 31-Jan-23 61732456 31-Mar-23 61736580 31-May-23 61739427 31-May-23 61744671 31-Jul-23 61747367 31-Aug-23 61750206 31-Aug-23 61752658 30-Sep-23 61761422 30-Nov-23 61776447 30-Apr-24 61780880 30-Apr-24 61802320 30-Sep-24 61806067 31-Oct-24 61807459 31-Oct-24 61822282 28-Feb-25

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0091-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0090-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-14
Z-0091-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-14
Z-0092-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-14

Product code FPA

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)