Medline Recalls RevMedX Trauma Dressings Due to Package Seal Integrity Issues
Medline Industries is recalling RevMedX Trauma Dressings because of package seal integrity issues. The recall affects 15,780 units distributed in the US and several international countries.
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medline Industries Inc is recalling RevMedX Trauma Dressings due to package seal integrity issues. The product is intended to absorb exudates and is packaged in a Tyvek Peel pouch. The recall involves 15,780 units.
The affected lots are 38217080001 (expiration 08/2022), 38217080002 (expiration 08/2022), 38217070001 (expiration 07/2022), and 38218050002 (expiration 05/2023). The item number is NONEX15182W. Distribution was worldwide, including the United States, Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.
The FDA has classified this as a Class II recall. Consumers and healthcare providers should check their inventory for the specific lot numbers listed above and stop using the affected products if they match the recall criteria.
The recalled product
- Product
- RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 15,780
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 (7)
- Item Number: NONEX15182W Lot Number/Expiration Date: 38217080001
- 08/2022
- 38217080002
- 38217070001
- 07/2022
- and 38218050002
- 05/2023
Distribution
Distributed nationwide across the United States.
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