Z-0150-2016Class II

Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional...

Name: Z-0150-2016 Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional...
Creator: B. Braun Medical, Inc.
Published: 2015-08-27
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2015-08-27 / Terminated / root cause: sterility

FDA source

B. Braun Medical, Inc. began a recall of Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management on 2015-08-27. FDA classified it as Class II and gives the reason as "Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0150-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-27
Posted: 2015-10-21
Terminated: 2016-06-29
Recalling firm: B Braun Medical Inc
Product: Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
Root cause tag: sterility
FDA 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 in commerce: 433
Distribution: Nationally
Product codes and lots: Product Catalog Number: 332215 332262 530024 530132 551714 551879 555184 555259 Lot Number 0061417406 0061421878 0061416371 0061420212 0061413247 0061416388 0061416389 0061414413

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0150-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0150-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21

Product code CAZ

K962696Class IIPerifix Pediatric Epidural KitB.Braun Medical, Inc. / cleared 1997-04-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)