Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0150-2016 · Posted None

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeCAZ
Date Initiated2015-08-27
Date Terminated2016-06-29
Product Quantity433

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationally

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962696PERIFIX PEDIATRIC EPIDURAL KITB.Braun Medical, Inc. · 1997-04-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑