Cardiosave battery charging station left bay screw prevents full battery insertion
Datascope is recalling the Battery Charging Station, model 0998-00-0802, because a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The rubric places FDA Class III recalls at 1 or 2, and this fault affects one bay of an optional accessory charger rather than the pump itself, with the second bay unaffected.
Plain-English summary
Datascope Corp. is recalling the Battery Charging Station, model 0998-00-0802. About 28 units were distributed, 20 in the United States across 11 states and 8 outside it, to Australia, Hong Kong, Israel, Japan and Norway. The FDA has classified this recall as Class III.
The Battery Charging Station is an optional dual-bay charger used to charge Cardiosave IABP lithium-ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay is not affected by this issue.
Affected product carries UDI 10607567111964, across 28 listed serial numbers.
Facilities can identify affected units by the model and serial numbers above, and may contact Datascope Corp. for further information.
The recalled product
- Product
- Battery Charging Station; Model: 0998-00-0802;
- Manufacturer
- Datascope Corp.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model: 0998-00-0802
- UDI: 10607567111964
- Serial Numbers: 200019347EAI
- 200019847EAI
- 200019447EAI
- 210018625EAI
- 210017925EAI
- 210017525EAI
- 210018425EAI
- 210020144EAI
- 210020944EAI
- 210022544EAI
- 210020244EAI
- 210022144EAI
- 210020044EAI
- 210020544EAI
- 210021344EAI
- 210023244EAI
- 210018025EAI
- 210019025EAI
Distribution
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