FDA-Device2022-10-05Class II
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
SunMed Holdings, LLC
Hazard
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.
Sold states
Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
Affected count
53,560 units
Manufactured in
2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, United States
Products
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1779-2022Don't want to check this manually?
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