Events

Recall of Integra Bone Marrow Biopsy Trays

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp. d.b.a. Integra Pain Management.

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
    72274
  • Event Risk Class
    Class 2
  • Event Number
    Z-0193-2016
  • Event Initiated Date
    2015-09-22
  • Event Date Posted
    2015-10-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140452
  • 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
    Syringe, piston - Product Code FMF
  • Reason
    Integra received an urgent drug recall notice from hospira inc. for their 1% lidocaine hcl injection, usp, 10 mg/ml, lot 44-359-dk. hospira inc. is recalling vials of lot 44-359-dk, 1% lidocaine hcl injection, usp, 10 mg/mlm distributed by hospira from february 2015 to march 2015 due to a confirmed complaint of visible, partially embedded particulate within a single-dose glass teartop vial.
  • Action
    Integra sent an Urgent Medical Device / Drug Recall Notice dated September 22, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed.to forward copies of the Integra and Hospira recall notification letters to their customers. Confirmation of recall notification delivery and instructed to stop use of devices and return to Integra. If you have questions of a customer service nature or beyond the information in the Hospira Inc. URGENT DRUG PRODUCT RECALL NOTICE, please contact either your local Integra Pain Management Sales Representative or customer service at 1-800-241-2210.

Device

Integra Bone Marrow Biopsy Trays
  • Model / Serial
    There are 3 Integra Lot Numbers affected by the recall of the single lot of Hospira Lidocaine: W1501193, W1504141, W1505078 Catalogue No. 3404253
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distributed to the state of : MD.
  • Product Description
    Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 || Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box.
  • Manufacturer
    Integra LifeSciences Corp. d.b.a. Integra Pain Management

Manufacturer

Integra LifeSciences Corp. d.b.a. Integra Pain Management
  • Manufacturer Address
    Integra LifeSciences Corp. d.b.a. Integra Pain Management, 3498 West 2400 South #1050, Salt Lake City UT 84119
  • Manufacturer Parent Company (2017)
    Integra LifeSciences Holdings Corporation
  • Source
    USFDA