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Terminated

BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,

FDA Recall Z-1649-2008 · Posted 2008-08-25

Recalling FirmSmiths Medical PM, Inc.
Recall StatusTerminated
Product CodeDXN
Date Initiated2008-04-02
Date Terminated2011-12-17
Product Quantity195

Reason for Recall

Due to a component that may be installed backwards, the device may turn off or may immediately reset.

Firm Action

Consignees were contacted on 4/2/08 with a Safety Action Bulletin, 08-SAB02, and Technical Worksheet 08-TW01 dated April 1, 2008, which included information regarding the potential safety issue and the proper inspection method for the monitor(s). If you have not received the Safety Action Bulletin or the Technical Worksheet contact Smiths Medical PM, Inc. at Telephone: (262) 542-3100 or Toll Free: (USA): (800) 558-2345 or email [email protected].

Root Cause

Employee error

Distribution Pattern

USA: IL, FL, TX, IA, CA, ID, MD, AZ, MN, PA, CO, IN, KS, WA, TN, AL, WI, NM, LA, and PR. OUSA: Argentina, Canada, Ecuador, Greece, Hong Kong, Italy, Pakistan, Peru, Russia, saudi Arabia, Slovakia, Thailand, United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031742BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETERBci, Inc. · 2003-08-18K984618BCI MINI-TORR PLUS, MODEL 6004Bci Intl., Inc. · 1999-03-25K9837966004 NIBP MONITOR WITH TEMPERATUREBci Intl., Inc. · 1999-01-22K970801BCI MODEL 6004 NIBP MONITOR (6004)Bci Intl., Inc. · 1997-11-12

Official Source

View FDA Recall →

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

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