Class 2 Device Recall Apellis Injection Kits

• Date Initiated by Firm: August 22, 2023
• Date Posted: September 29, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2653-2023
• Recall Event ID: 92926
• 510(K)Number: K222681
• Product Classification: Needle, hypodermic, single lumen - Product Code FMI
• 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
• Code Information: UDI-DI: 00860008043672 Kit Lots: 223186 230036 230056 230236 230316 230326 230336 230406 231926 231946 231956 231986
• Recalling Firm/ Manufacturer: Apellis Pharmaceuticals, Inc.; 100 5th Ave Fl 3; Waltham MA 02451-8727
• For Additional Information Contact: 617-977-5700
• Manufacturer 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
• FDA Determined 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 in Commerce: 61,943 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FMI