Class II — Summit Medical, Inc.
| Recalling firm | Summit Medical, LLC |
|---|---|
| Registered facility | SUMMIT MEDICAL LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog # RH-7413-10, Lot # 160889 & 161354 because the product does not have the split in the packing. |
| 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. |
| Quantity | 9 boxes (10 /box) |
| Distribution | Distributed to CA. |
| Initiated | 2015-09-03 |
| Classified | 2015-12-16 |
| Terminated | 2016-05-02 |
| Recall number | Z-0435-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Summit Medical, Inc. (Z-0435-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72276/
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