Getinge CO2 Absorber Recalled for Reversed Expiration and Manufacturing Dates
Getinge is recalling 1,444 boxes of disposable CO2 absorbers because the expiration and manufacturing dates on the labels are reversed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 for a documentation and labeling issue (reversed dates) without reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
Getinge US Sales LLC is recalling 1,444 boxes of Getinge MCC Flow i Disposable CO2 absorbers used in anesthesia systems. The recall is due to a labeling error where the expiration and manufacturing dates are reversed on the product label.
The affected products were distributed nationwide in the United States. The specific lots involved are 1810 and 1811, with part numbers 6677845 (12 pcs) and 6673717 (1 pc). The UDI code for the product is 17325710001988.
Healthcare facilities should check their inventory for these specific lot numbers and part numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
- Manufacturer
- GETINGE US SALES LLC
- Hazard
- Affected units
- 1,444
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 (3)
- Lot # 1810
- 1811 Part Number: 6677845 for 12 pcs
- 6673717 for 1 pcs UDI Code: 17325710001988
Distribution
Distributed nationwide across the United States.
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