Class II — SunMed Holdings, LLC
| Recalling firm | SunMed Group Holdings, LLC dba AirLife |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle. |
| Product | Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 |
| Quantity | 53,560 units |
| Distribution | Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX. |
| Initiated | 2022-09-08 |
| Classified | 2022-09-23 |
| Terminated | 2024-06-18 |
| Recall number | Z-1779-2022 |
| 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 — SunMed Holdings, LLC (Z-1779-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90834/
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