Recall archive / FDA device enforcement
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 — FDA record Z-1779-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 8, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- SunMed Holdings, LLC
- Quantity
- 53,560 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-1779-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 5, 2022
- Recall initiation date
- Sep 8, 2022
- Center classification date
- Sep 23, 2022
- Termination date
- Jun 18, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.