Reported Oct 5, 2022 · Terminated
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
SunMed Holdings, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SunMed Holdings, LLC · 2710 Northridge Dr Nw Ste A · Grand Rapids, MI · 49544-9112
Is this the product you have?
- Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
- Lot codes and dates
- UDI-DI
00709078004483 (each label)10709078004480 (box label) Lots 010822N23052521N54081821N05101221N11
- UDI-DI
- Amount recalled
- 53,560 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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