SunMed Holdings, LLC: Medical Device Recall in 2022 - (Recall #: Z-1779-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 8, 2022

Date Posted: October 5, 2022

Recall Number: Z-1779-2022

Event ID: 90834

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.

Status: Terminated

Product Quantity: 53,560 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated