Reported Oct 11, 2023 · Ongoing
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts…
Apellis Pharmaceuticals, Inc.
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: Apellis Pharmaceuticals, Inc. · 100 5th Ave Fl 3 · Waltham, MA · 02451-8727
Is this the product you have?
- Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle
- RefIVT-KIT-29G
- Lot codes and dates
- UDI-DI00860008043672
- Kit Lots
223186230036230056230236230316230326230336230406231926231946231956231986
- Amount recalled
- 61,943 units
Where it was sold
- Nationwide
Why it was recalled
19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis
This product could cause temporary or reversible health problems — stop using it.
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