Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH — Class II medical device recall Z-1779-2022
Terminated recall by SunMed Holdings, LLC, reported 2022-10-05, distributed in AL, FL, GA, IL, LA, MO, NJ, NY…. The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a
| Recall number | Z-1779-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SunMed Holdings, LLC, Grand Rapids, MI, United States |
| Recall initiated | 2022-09-08 |
| Classified | 2022-09-23 |
| Reported by FDA | 2022-10-05 |
| Terminated | 2024-06-18 |
| Distributed | AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX |
| Quantity | 53,560 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00709078004483, 10709078004480 |
| Lot numbers | 010822N23, 052521N54, 081821N05, 101221N11 |
| Model numbers | 3373-91 |
Product
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1779-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.