FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Perifix / Epidural anesthesia set, medicated
- Recall number
- Z-2627-2023
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Perifix / Epidural anesthesia set, medicated
- Status
- Open, Classified
- Initiated
- 2023-07-31
- Posted
- 2023-09-21
- Terminated
- not on file
- Reason
- Product may be mislabeled with an incorrect lid stock label.
- Root cause
- Process control
- Action
- An "URGENT MEDICAL DEVICE RECALL" letter dated 8/14/23 was issued to affected customers on 08/14/2023. The letter described the product, problem and actions to be taken. The Customers are instructed to review inventory, cease use and quarantine impacted product and complete and return the Product Recall Acknowledgement Form back to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610)849-1197 or email to PA_QualityAssurance.BBMUS_Service@bbraunusa.com. B. Braun Medical will facilitate return of impacted product. If you have any questions, contact BBMI's Postmarket Surveillance Department at 1-833-425-1464.
- Quantity
- 3440 units
- Distribution
- US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, WA
- Lot, serial or model codes
- UDI-DI: 04046964178726 Product Code: 332250; Lot Number 0061863524, expiration date 30.APR.2025
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OGE
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28