Class 2 Device Recall Oxy Serve II Oxygen Conserving Regulator

• Date Initiated by Firm: October 19, 2007
• Date Posted: January 23, 2008
• Recall Status: Terminated on April 25, 2012
• Recall Number: Z-0529-2008
• Recall Event ID: 45482
• 510(K)Number: K051988
• Product Classification: Oxygen Regulator - Product Code NFB
• Product: Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144
• Code Information: 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)
• FEI Number: 1000515374
• Recalling Firm/ Manufacturer: Superior Products Inc; 3786 Ridge Rd; Cleveland OH 44144-1127
• For Additional Information Contact: 216-651-9400 Ext. 144
• Manufacturer Reason for Recall: Leakage: Device was leaking oxygen
• FDA Determined Cause: Component design/selection
• 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.
• Quantity in Commerce: 125
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NFB