C.R. Bard Recalls Arctic Sun ArcticGel Pads Due to Labeling Error
C.R. Bard is recalling 128 units of Arctic Sun ArcticGel Pads - Medium because the product box displays an incorrect reference number.
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 indicates the product is unlikely to cause adverse health consequences. The issue is a minor labeling error on the outer box, which falls under the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
C.R. Bard, Inc. is recalling 128 units of Arctic Sun ArcticGel Pads - Medium, Product Code 317-07. The recall is due to a labeling error where the product box contains the incorrect reference number #317-09. The shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.
The affected units were distributed domestically and internationally to Australia and Belgium. The specific lot number is NGAR0462, and the device listing number is D234021.
Consumers and healthcare providers should stop using the affected product and contact C.R. Bard, Inc. for instructions on how to return or dispose of the units.
The recalled product
- Product
- Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Cryotherapy
- Hazard
- Affected units
- 128
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)
- Product code 317-07
- Lot Number NGAR0462
- Device Listing Number D234021.
Distribution
Distribution scope not specified by the agency.
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