FDA Device recall Z-1779-2022
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
- FDA Device
- Class II
- terminated
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 by Sunmed Holdings, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1779-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-09-08 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sunmed Holdings |
| Distribution | AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX |
Product
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
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.
Identifiers
| code_info | UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1779-2022%22
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