LivaNova Sorin Connect Datapad Recall for Incorrect Manufacturing Date Labels
LivaNova USA Inc. is recalling five Sorin Connect Datapad devices because they have incorrect manufacturing date labels. The devices were distributed in New Jersey and California.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is limited to documentation and labeling errors regarding dates.
Plain-English summary
LivaNova USA Inc. is recalling five Datapad devices from the Sorin Connect DPIII KOMPL. S5 system. The S5 System is used to perform, control, and monitor extracorporeal blood circulation during operations for up to six hours.
The recall was initiated due to incorrect labeling on the devices. Specifically, the manufacturing date in the production identifier was incorrect, and the manufacturing date on the unique device identifier label was formatted as yy-mm-dd instead of the required yyyy-mm-dd format.
The affected devices were distributed in New Jersey and California. The specific serial numbers involved are 17BQC0247, 17BQC0249, 17BQC0250, 17BQC0258, and 17BQC0257.
The recalled product
- Product
- LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
- Manufacturer
- LivaNova USA Inc.
- Hazard
- Affected units
- 5
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 (10)
- Device Model
- Catalog Number
- Serial Number: SORIN CONNECT DPIII KOMPL. S5
- 24-90-80
- 17BQC0247 SORIN CONNECT DPIII KOMPL. S5
- 17BQC0249 SORIN CONNECT DPIII KOMPL. S5
- 17BQC0250 SORIN CONNECT DPIII KOMPL. S5
- 17BQC0258 DATAPADIII WITHOUT SOFTWARE
- 24-90-87
- 17BQC0257
Distribution
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