Z-1509-2021Class II

Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 -

Name: Z-1509-2021 Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 -
Creator: B. Braun Medical, Inc.
Published: 2021-03-15
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2021-03-15 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile... on 2021-03-15. FDA classified it as Class II and gives the reason as "BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1509-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-15
Posted: 2021-04-29
Terminated: 2022-06-07
Recalling firm: B Braun Medical Inc
Product: Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.
Product code: FPA Set, Administration, Intravascular
Reason for recall: BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
FDA root cause: Under Investigation by firm
Action: On 03/12/2021, B. Braun issued an Urgent Medical Device Recall notice via letter notifying customers of the potential for the extension set to become occluded or unable to prime.
Quantity in commerce: 1,900 units
Distribution: US Nationwide distribution in the states of NC, CA.
Product codes and lots: Lot #: 00SL713784, 0061741483, 0061755034, 0061755296

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1509-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1509-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-29

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)