Apellis Pharmaceuticals, Inc.: 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

Recall number

Z-2653-2023

Recalling firm

Apellis Pharmaceuticals, Inc.

Product

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

Status

Open, Classified

Initiated

2023-08-22

Posted

2023-09-29

Terminated

not on file

Reason

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

Root cause

Under Investigation by firm

Action

Apellis issued Medical Device Field Correction letters via email on 8/22/23 to Healthcare Practitioners and Distributors/Specialty Distributors and Pharmacy/ Logistics. The communication to the Healthcare Practitioners also includes update on the rare events of retinal vasculitis with real world use of SYFOVRE (pegcetacoplan injection). A causal relationship has not been established between the 19-gauge needle and the rare events of retinal vasculitis in the real world. Letter states reason for recall, health risk and action to take: Actions to be taken by the Customer/Distributor: Please note that as part of this field action, you are requested to: " Confirm your availability and participation by sending back an email to acknowledge receipt of this message. " Immediately cease distribution of the below injection kit lots and place any remaining inventory of the lots On Hold. " Provide a summary of current on-hand inventory of the injection kit lots below. " Provide a distribution report of the injection kit lots including customer name/address, lot shipped, quantity shipped, and date. Please provide the Distribution report in a maximum time of four business hours. Apellis will also be recommending that practitioners discontinue use of, and dispose, any remaining injection kits that contain the specific 19-gauge filter needle and recommend they instead use the injection kits containing the 18-gauge filter needle already in distribution. Apellis is now exclusively distributing injection kits with the 18-gauge filter needle. If you need to place a supplemental order to replace quarantined lots, please place them immediately through your normal ordering process and Apellis will expedite shipping replacement injection kits./ Apellis will also be notifying physicians that if they do not have an injection kit with the 18-gauge filter needle, they may request a new kit at no cost by emailing info@apellis.com or contacting their Apellis Territory Business Mana

Quantity

61,943 units

Distribution

US Nationwide distribution.

Lot, serial or model codes

UDI-DI: 00860008043672 Kit Lots: 223186 230036 230056 230236 230316 230326 230336 230406 231926 231946 231956 231986

510(k) numbers

["K222681"]

PMA numbers

not on file

Product code

FMI

Firm FEI

3016603289

Firm city

Waltham

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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