Tonsil tray kits recalled for containing component under improper use recall
Windstone Medical Packaging recalls 642 kits of Aligned Medical Tonsil Trays because they contain Cardinal Health Salem Sump PVC tubes that are subject to a separate recall for improper use.
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: FDA Class II recall with no reported illnesses, injuries, or deaths mentioned in the source. The hazard involves improper use of a surgical component, constituting a risk-of-harm product where injury has not been reported, fitting the High severity criterion.
Plain-English summary
Windstone Medical Packaging, Inc., is recalling 642 kits of the Aligned Medical Tonsil Tray (Catalog Number AMS9300A) because the kits contain a component—the Cardinal Health Salem Sump PVC tubes—that is subject to a separate recall for improper use.
The affected trays were distributed in California, Missouri, Ohio, Virginia, and Wyoming. The affected lot numbers are 168030, 171362, 172981, 177913, 179608, 181537, 185126, 189873, 189874, 196460, 196461, 198850, 200902, 206846, 208255, and 209391.
Healthcare facilities should discontinue use of the affected lots and contact Windstone Medical Packaging, Inc., for instructions on replacement or proper disposal.
The recalled product
- Product
- Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- Affected units
- 642
Distribution
Part of a larger recall action
This product is one of 5 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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