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Terminated

Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144

FDA Recall Z-0529-2008 · Posted 2008-01-23

Recalling FirmSuperior Products Inc
Recall StatusTerminated
Product CodeNFB
Date Initiated2007-10-19
Date Terminated2012-04-25
Product Quantity125

Reason for Recall

Leakage: Device was leaking oxygen

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

Worldwide-USA including states of CA, FL, IA, IN, KY, OH, SC, TX, and WA. and countries of Singapore, Mexico City, MX, and Turkey

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051988OXY-SERVE II OXYGEN CONSERVING REGULATORSuperior Products, Inc. · 2005-09-21

Official Source

View FDA Recall →

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

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