Recall Z-1779-2022— SunMed Holdings, LLC

Name: FDA recall Z-1779-2022
Creator: U.S. Food and Drug Administration
Published: 2022-09-08

Class II · Terminated

Class II FDA medical device recall by SunMed Holdings, LLC, initiated 2022-09-08, terminated 2024-06-18. It names one FDA 510(k) clearance: K944941. 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..

Recalling firm: SunMed Holdings, LLC
Classification: Class II
Status: Terminated
Initiated: 2022-09-08
Terminated: 2024-06-18
Firm location: Grand Rapids, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K944941 — PISTON SYRINGEMartell Medical Products, Inc.·cleared 1994-12-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.