Drug recall
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
FDA recall event 90834 · Class II · SunMed Holdings, LLC
Key facts
| Event ID | 90834 |
|---|---|
| Recall numbers | Z-1779-2022 |
| Recalling firm | SunMed Holdings, LLC |
| Product type | Devices |
| Products | Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 8, 2022 |
| Report date | Oct 5, 2022 |
| Termination date | Jun 18, 2024 |
| City | Grand Rapids |
| State | MI |
| Country | United States |
| FEI number | 1314417 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: