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
- Recall Number
- Z-2653-2023
- Event Number
- 92926
- Firm
- Apellis Pharmaceuticals, Inc.
- FEI Number
- 3016603289
- Product Code
- FMI
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- August 22, 2023
- Posted
- September 29, 2023
- Address
- 100 5th Ave, Fl 3, Waltham, MA, 02451-8727
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
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
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
US Nationwide distribution.
61,943 units