FDAOctober 22, 2024device
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
What to do
FDA enforcement status: Ongoing
Brands named
carwild
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAIvalon 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: Q7704102024-10-22
- FDAIvalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q6042062024-10-22
- FDAFABCO 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: 349115102022-08-02
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