Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of
Summary
The FDA issued a Class II for Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids by Apellis Pharmaceuticals, Inc.. Reason: 19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been establis.
Details
Source
Device Recall
External ID
Z-2653-2023
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
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. Ref: IVT-KIT-29G
Lot/Code Info: UDI-DI: 00860008043672 Kit Lots: 223186 230036 230056 230236 230316 230326 230336 230406 231926 231946 231956 231986
Quantity Affected: 61,943 units
Reason for Recall
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
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-22
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Apellis Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apellis Pharmaceuticals, Inc. have FDA actions?
This is the only FDA action we have on record for Apellis Pharmaceuticals, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2653-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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