—#140317

Product

Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K962696
Affected lot / code info: Product Catalog Number: 332215 332262 530024 530132 551714 551879 555184 555259 Lot Number 0061417406 0061421878 0061416371 0061420212 0061413247 0061416388 0061416389 0061414413

Why it was recalled

Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Nationally

Timeline

Recall initiated: 2015-08-27
Terminated: 2016-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140317. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.