Summit Medical Recalls AbsorbENT Nasal Packs Due to Missing Split
Summit Medical is recalling specific lots of AbsorbENT nasal packs because the product lacks a required split in the packing.
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, and the defect is a structural/packaging issue without reported injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Summit Medical, Inc. is recalling 9 boxes (10 per box) of AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, Catalog # RH-7413-10. The affected lots are 160889 and 161354. The product is a prescription-only medical device used as a nasal packing following intranasal surgery to absorb blood and other fluids.
The recall was initiated because the product does not have the split in the packing. The source text does not specify the clinical consequences of this defect or report any injuries or illnesses.
The affected products were distributed to California. Consumers and healthcare providers should stop using the affected lots and contact Summit Medical, Inc. for further instructions or a return.
The recalled product
- Product
- AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
- Manufacturer
- Summit Medical, Inc.
- Hazard
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)
- 160889
- 161354
Distribution
Distributed in 1 state:
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