Events

Recall of Device Recall PENCAN Spinal Anesthesia Tray

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by B. Braun Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78878
  • Event Risk Class
    Class 2
  • Event Number
    Z-0572-2018
  • Event Initiated Date
    2017-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160791
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Needle, hypodermic, single lumen - Product Code FMI
  • Reason
    B. braun medical inc. (bbmi) initiated this recall of various bbmi convenience kits containing the 22ga 1-1/2in safetyglide needle due to the presence of loose polypropylene foreign matter was above release specification. this foreign matter has been identified as a product hub material which has been tested for biocompatibility per iso 10993 during the product development process.
  • Action
    The firm, BD, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 6/12/2017 to its customers/kit packers. B.Braun Medical Inc. (BBMI), sent a "VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter dated 6/23/2017 to all BBMI customers in receipt of suspect product. Customers were notified by US Postal Service Certified Mail with registered return receipt mail or FedEx Priority. The letters described the product, problem and actions to be taken. The customers were instructed to review the device notification in its entirety and inform all users of the recall; determine your inventory of the affected product-Do not destroy any affected product; complete and return the "Product Removal Acknowledgement" form to B.Braun Medical Inc. Quality Assurance department via fax to 610-849-1197 or email to PA_QualityAssurance.BBMUS_Service@bbraun.com within two 2 weeks of receipt, even if the total inventory in your possession is zero 0; and if you have any full cases, partial cases or unused individual pieces a BBMI Customer Support Representative will contact you to provide instructions for handling affected product and arrange for return. Should you have any questions or concerns regarding the recall, please contact our Customer Support Department at 800-227-2862.

Device

Device Recall PENCAN Spinal Anesthesia Tray
  • Model / Serial
    0061525340. 0061535836.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. || Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Manufacturer Address
    B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA