Medline Recalls Sensicare Green Surgical Gloves Due to Potential Sterility Breach
Medline Industries is recalling 8,000 units of Sensicare Green Surgical Gloves because a possible open seal on the packaging could compromise sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile surgical gloves) where a breach of sterility could lead to infection, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Medline Industries Inc is recalling 8,000 units of Sensicare Green Surgical Gloves, Model No. MSG1285, Lot No. 701893369485. The recall was initiated because the top portion of the poly/poly peel pouch packaging may have an open seal. This defect could cause a breach of sterility, rendering the sterile surgical gloves unsafe for use.
The affected products were distributed worldwide, including across the United States and Canada. The source text does not specify the exact number of units distributed in each location or the specific dates of distribution.
Consumers and healthcare facilities should stop using the affected gloves immediately. Users should check their inventory for the specific model and lot numbers listed above. If the product is found, it should be quarantined and returned to Medline Industries Inc or the original supplier for credit or replacement.
The recalled product
- Product
- Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Gloves
- Affected units
- 8,000
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)
- Model No. MSG1285
- Lot No. 701893369485
Distribution
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