Recall Z-2304-2019
Becton Dickinson & Company · initiated June 12, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
Codes / lots: UDI: (01)30382903679639
Reason for recall
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
FDA-determined cause: Device Design
Action taken
Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers.
Details
- Recall number
- Z-2304-2019
- Initiated
- June 12, 2019
- Terminated
- June 29, 2020
- Product code
- JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
- Quantity
- 1,436,228,004 total
- Distribution
- Worldwide Distribution, including US Nationwide
- Recalling firm
- Becton Dickinson & Company, Franklin Lakes, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2296-2019 Class II | BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2297-2019 Class II | BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2298-2019 Class II | BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2299-2019 Class II | BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2300-2019 Class II | BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2301-2019 Class II | BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2302-2019 Class II | BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2303-2019 Class II | BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2305-2019 Class II | BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2306-2019 Class II | BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2307-2019 Class II | BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2308-2019 Class II | BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2309-2019 Class II | BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2310-2019 Class II | BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |