New London, CT, United States
Carwild Corporation recalls
2 recalls recorded since 2018, most recently on 22 October 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 October 2024
- Reason
- Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
- Distribution
- IL, FL, SC. PA, AL Foreign: Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0799-2025, Z-0798-2025, Z-0800-2025
- Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
- Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
- Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410
Ongoing Class II Medical devices
- Recall started
- 2 August 2022
- Reason
- Sterility with new cotton source not validated
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1747-2022
- FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.