Z-2003-2023Class II

Design Options / Epidural anesthesia kit (10 count carton)

Name: Z-2003-2023 Design Options / Epidural anesthesia kit (10 count carton)
Creator: B. Braun Medical, Inc.
Published: 2023-06-05
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2023-06-05 / Open, Classified

FDA source

B. Braun Medical, Inc. began a recall of Design Options / Epidural anesthesia kit (10 count carton) on 2023-06-05. FDA classified it as Class II and gives the reason as "Kits were assembled with the incorrect Filter Straw". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2003-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-05
Posted: 2023-06-23
Recalling firm: B Braun Medical Inc
Product: Design Options / Epidural anesthesia kit (10 count carton)
Product code: OGE Epidural Anesthesia Kit
Reason for recall: Kits were assembled with the incorrect Filter Straw.
FDA root cause: Mixed-up of materials/components
Action: Customers received a recall notification dated 06/05/2023 by mail notifying them that affected lots of Epidural Kits were inadvertently assembled with the incorrect Filter Straw. The recall notification asks customers to determine if any affected devices are in inventory and subsequently quarantine any identified product, return the Product Recall Acknowledgement Form notating any affected devices currently in quarantine, and return the form by fax to 610-849-1197 or by email to [email protected]. Coordination of product return for provision of credit/replacement will commence upon return of the form. If product has been further distributed the firm asks that the recall notification be forwarded to those consignees down to the consumer level. Customers with any questions can direct them to BBMI's Postmarket Surveillance Department at 1-883-425-1464.
Quantity in commerce: 3,560 units
Distribution: US Nationwide distribution.
Product codes and lots: Model No. 552177, 552155, 552179, 552116; GTIN: 04046955596102, 04046955214440, 04046955596140, 04046964950254; Lot No. 0061853751, 0061854949, 0061855598, 0061855133.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2003-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2002-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-23
Z-2003-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-23

Product code OGE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)