FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
- Recall number
- Z-0150-2016
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
- Status
- Terminated
- Initiated
- 2015-08-27
- Posted
- not on file
- Terminated
- 2016-06-29
- Reason
- Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
- Root cause
- Under Investigation by firm
- Action
- BBMI provided written notification, dated August 27, 2015, to all customers in receipt of suspect product, along with acknowledgement forms detailing the suspect product that was distributed to each account. These customers include both BBMI direct end customers and BBMI direct distributors. Customers were notified by US Postal Service Certified Mail with registered return receipt mail or FedEx Priority. All customers were provided with instructions for disposition of suspect product in their inventory. Distributors shall be reminded of their responsibility in executing the recall.
- Quantity
- 433
- Distribution
- Nationally
- Lot, serial or model codes
- Product Catalog Number: 332215 332262 530024 530132 551714 551879 555184 555259 Lot Number 0061417406 0061421878 0061416371 0061420212 0061413247 0061416388 0061416389 0061414413
- 510(k) numbers
- ["K962696"]
- PMA numbers
- not on file
- Product code
- CAZ
- 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