Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Datascope Corp.
- Recall Initiated
- April 5, 2004
- Posted
- July 20, 2004
- Terminated
- January 19, 2005
- Recall Number
- Z-1050-04
- Quantity
- 202
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Potential inaccurate printed information in the upper and lower margins of a print strip.
Distribution
The units were shipped to hospitals and clinics nationwide. Also to Australia, Brazil, Belgium, France, Germany,Turkey, United Kingdom, United Arab Emirates. One unit was shipped to the VA Medical Center, Augusta, GA.
Lot / Code Info
Serial Numbers: CM16830-E2; CM17664-C3; CM02100-D0; CM21267-B3; CM01262-B0; CM17728-F3; CM14167-L1; CM15062-B2; TM05314-D3; TM03604-A3; TM03630-A3; TM03642-A3; TM04059-B3; CM11122-F1; CM02057-D0; CM10756-F1; CM01376-B0; CM06107-K0; CM08770-C1; CM04116-H0; CM03838-G0; CM15058-B2; CM10359-F1; TM04721-C3; CM03958-G0; CM12388-I1; CM11462-G1; TM04175-B3; CM04386-H0; CM04445-H0; CM12571-I1; CM12778-I1; CM11479-G1; CM11776-H1; CM03556-F0; CM17319-E2; TM03982-A3; CM10360-F1; CM13887-K1; TM06058-F3; CM07526-B1; CM17683-F3; CM17715-F3; CM14479-A2; CM04265-H0; CM04703-I0; CM16756-E2; TM04809-C3; TM01569-H2; TM03602-A3; TM03603-A3; TM04091-B3; CM14979-B2; CM14986-B2; CM09445-D1; CM09479-D1; CM09935-E1; CM10117-E1; CM16268-D2; CM16451-D2; CM16540-D2; CM20116-F2; CM20117-F2; CM20130-F2; CM20160-F2; CM20196-F2; CM20203-F2; CM20216-F2; CM20218-F2; CM20219-F2; CM20220-F2; CM20221-F2; CM20529-F2; CM20531-F2; CM20533-F2; CM20537-F2; CM20538-F2; TM03635-A3; TM03639-A3; TM03647-A3; TM05447-E3; TM05457-E3; TM06085-G3; TM06109-G3; TM06119-G3; TM06129-G3; TM06152-G3; TM06154-G3; TM06170-G3; TM06270-H3; TM06280-H3; TM06282-H3; TM06317-H3; TM06337-H3; TM06363-H3; TM06386-H3; CM12173-H1; CM03670-F0; CM10041-E1; CM10721-F1; CM17422-E2; CM14065-L1; CM01200-L9; CM10711-F1; CM13006-J1; CM09686-D1; CM16023-C2; CM07488-B1; CM06584-L0; CM14498-A2; CM11945-H1; CM09924-E1; CM10163-E1; TM0555733-E3; CM12712-I1; TM04453-B3; TM03615-A3; CM04707-I0; CM08494-C1; TM04593-B3; TM06051-F3; CM04641-I0; CM12252-H1; CM16585-D2; CM04089-H0; CM09094-D1; TM06056-F3; TM06057-F3; TM06060-F3; YM06061-F3; CM06521-L0; CM04176-H0; TM01305-H2; TM03623-A3; TM03637-A3; TM03631-A3; CM04739-I0; CM13335-J1; CM05366-J0; CM05379-J0; CM07674-B1; CM12608-I1; CM04078-H0; TM01934-I2; TM03605-A3; TM03614-A3; CM05787-K0; CM12519-I1; CM16699-E2; CM09685-D1; CM10622-F1; CM13227-J1; CM17680-E3; TM02741-K2; CM05243-J0; CM05992-K0; CM13985-L1; TM05504-E3; TM03338-L2; CM11689-H1; TM04360-B3; CM03934-G0; CM10757-F1; CM10768-F1; CM10771-F1; TM05692-E3; TM05710-E3; CM1099-L9; CM17684-F3; CM16059-C2; CM03133-E0; CM01660-C0; CM15956-C2; CM14371-LI; CM06098-K0; CM07733-B1; CM09173-D1; CM06805-L0; CM10013-E1; CM04005-G0; CM07697-B1; TM05835-F3; TM05840-F3; TM05854-F3; TM05872-F3; TM05905-F3; TM05912-F3; TM05921-F3; TM05947-F3; TM05956-F3; CM01797-C0; TM02210-J2; CM05139-J0; CM11127-F1; TM01614-H2; CM09611-D1; TM05714-E3; TM03476-A3; TM03627-A3; TM03684-A3; TM05824-E3; CM07628-B1.
Root Cause
Other
Action Taken
Datascope initiated this field action in February, 2004. Datascope Service Representatives are visiting the customers and doing the retrofit.