Z-2653-2023Class II

Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids...

Name: Z-2653-2023 Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids...
Creator: Apellis Pharmaceuticals, Inc.
Published: 2023-08-22
License: https://open.fda.gov/license/

Apellis / initiated 2023-08-22 / Open, Classified

FDA source

Apellis Pharmaceuticals, Inc. began a recall of 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... on 2023-08-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2653-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-22
Posted: 2023-09-29
Recalling firm: Apellis
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
Product code: FMI Needle, Hypodermic, Single Lumen
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 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 [email protected] or contacting their Apellis Territory Business Mana
Quantity in commerce: 61,943 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 00860008043672 Kit Lots: 223186 230036 230056 230236 230316 230326 230336 230406 231926 231946 231956 231986

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2653-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2653-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29

Product code FMI

K222681Class IIAltaviz Needle KitAltaviz, LLC / cleared 2022-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)