Remington Medical drainage bags recalled due to packaging label date error
Remington Medical is recalling drainage bags (Lot 2325111) due to errors in the 'Use by Date' and 'Date of Manufacturer' on box labels. Approximately 3,080 units distributed in PA and FL are affected.
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 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: FDA Class II medical device recall for labeling error with no reported adverse events or illnesses. Per the rubric, minor labeling errors without reported harm classify as Moderate severity.
Plain-English summary
Remington Medical, Inc. is recalling the Remington MEDICAL Drainage Bag, REF 600-D, due to errors on the product box label. The printed 'Use by Date' and 'Date of Manufacturer' are incorrect.
Approximately 3,080 units with Lot Number 2325111 were distributed in Pennsylvania and Florida. Consumers and healthcare providers with affected products should contact the manufacturer for corrected dating information.
The labeling error prevents accurate determination of product validity. Affected consumers should contact Remington Medical, Inc. for accurate product information before use.
The recalled product
- Product
- Remington MEDICAL Drainage Bag, REF 600-D;
- Manufacturer
- Remington Medical, Inc.
- Category
- Medical Device — Drainage Bag
- Hazard
- Affected units
- 3,080
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)
- UDI/DI 20813079020008
- Lot Number 2325111
Distribution
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