BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,
FDA device recall Z-1649-2008 · posted 2008-08-25 · Terminated
Recall details
- Recalling firm
- Smiths Medical PM, Inc.
- Reason for recall
- Due to a component that may be installed backwards, the device may turn off or may immediately reset.
- Action taken
- 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 info.pm@smiths-medical.com.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DXN
- Quantity affected
- 195
- Distribution
- 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, Tha
- Date initiated
- 2008-04-02
- Date posted
- 2008-08-25
- Date terminated
- 2011-12-17
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER (K031742) | Bci, Inc. | 2003-08-18 |
| BCI MINI-TORR PLUS, MODEL 6004 (K984618) | Bci Intl., Inc. | 1999-03-25 |
| 6004 NIBP MONITOR WITH TEMPERATURE (K983796) | Bci Intl., Inc. | 1999-01-22 |
| BCI MODEL 6004 NIBP MONITOR (6004) (K970801) | Bci Intl., Inc. | 1997-11-12 |