Arc Medical Recalls ThermoFlo 1 HME Due to Incorrect Outer Carton Expiry Date
Arc Medical Inc is recalling 1,810 units of ThermoFlo 1 HME because the outer shipping carton displayed an incorrect expiry date, although the inner product carton was labeled correctly.
What this means for you
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 the rubric defines as unlikely to cause adverse health consequences. The issue is a packaging labeling error on the outer carton, which falls under the 'packaging-only problems' criterion for a Low severity score.
Plain-English summary
Arc Medical Inc is recalling 1,810 units of ThermoFlo 1 HME, a disposable, non-sterile humidifier used in breathing circuits. The recall is limited to product code 6160, batch number 110208-50, with an expiry date of 04/17.
The recall was initiated because the outer shipping carton was marked with an incorrect expiry date. The source text notes that the inner product carton was labeled correctly. The affected units were distributed in California and North Carolina.
This is an FDA Class III recall, which indicates that the product is not likely to cause adverse health consequences. Consumers and healthcare facilities should check the outer shipping cartons for the incorrect date and contact Arc Medical Inc for further instructions.
The recalled product
- Product
- ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
- Manufacturer
- Arc Medical Inc
- Hazard
- Affected units
- 1,810
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 (2)
- Product code: 6160
- Batch number: 110208-50
Distribution
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