Recall Z-2653-2023 ยท FMI Needle, Hypodermic, Single Lumen
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
| Date | Sep 29, 2023 (initiated Aug 22, 2023) |
| Status | Open, Classified |
| 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 not |
| Quantity | 61,943 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222681 | Altaviz Needle Kit Altaviz, LLC, Dec 5, 2022 |