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Recall Observatory FDA recall evidence

Device product

Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91

Z-1779-2022

September 08, 2022

Class II

Product summary

Firm
SunMed Holdings, LLC
Event
Event 90834
Status
Terminated
Classification
Class II
Quantity
53,560 units
Official record key
device-enforcement:Z-1779-2022

Official wording

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.

Code information: UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11

Distribution pattern: Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    lack of sterility