Events

Recall of Oxy Serve II Oxygen Conserving Regulator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Superior Products 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
    45482
  • Event Risk Class
    Class 2
  • Event Number
    Z-0529-2008
  • Event Initiated Date
    2007-10-19
  • Event Date Posted
    2008-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65564
  • 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
    Oxygen Regulator - Product Code NFB
  • Reason
    Leakage: device was leaking oxygen.
  • Action
    A Voluntary Medical Device Recall notification was delivered by certified mail on or about 10/19/2007, to all consignee's; "bill to" and "sent to." Consignee's are asked to contact their customers (if any), notify them of the recall, and return all implicated products to Superior Products.

Device

Oxy Serve II Oxygen Conserving Regulator
  • Model / Serial
    Lot 051101 - (Serial #'s: 001009, 001010, 001012, 001017, 001019, 001023, 001025, 001027, & 001029) -- Lot 05111 - (Serial #: 001049)-- Lot 051121 (Serial #'s: 001022, 001015, 001026, 530002, 530004, 001013, 001014, 001016, & 001034)-- Lot 051130 (Serial #'s: 530003, 001011, 001018, 001021, 001024, 001031, 001033, 001035, 001037, 001038, 001039, & 001050) -- Lot 051202 (Serial # 001044)-- Lot 063759 (Serial #'s: 001206, 001054, 001055, 001056, 001073, 001077, 001164, 001168, 001180, 001191, 001207, 001078, 001166, 001154, 001178, 001169, 001170, 001174, 001153, 001155, 001157, 001171, 001175, 001177, 001182, 001200, 001203, 001208, 001140, & 001165) Lot 063426 (Serial # 001093, 001101, 001111, 001128, 001106, 001114, 001076, 001112, 001074, 001084, 001092, 001124, 001126, 001134, 001137, 001141, 001142, 001167, 001069, 001057, 001099, 001130, 001135, 001150, 001118, 001139, 001075, 001052, 001117, 001119, 001176, 001061, 001053, 001103, 0011363, 001108, 001067, 001110, 001070, 001136, 001098, 001121, 001113, 001051, 001063, 001082, 001071, 001116, 001064, 001066, 001095, 001109, 001085, 001087, 001088, 001089, 001090, 001091, 001094, 001096, 001125, 001127, 001144, & 001145)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA including states of CA, FL, IA, IN, KY, OH, SC, TX, and WA. and countries of Singapore, Mexico City, MX, and Turkey
  • Product Description
    Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144
  • Manufacturer
    Superior Products Inc

Manufacturer

Superior Products Inc
  • Manufacturer Address
    Superior Products Inc, 3786 Ridge Rd, Cleveland OH 44144-1127
  • Source
    USFDA