Recall Z-2514-2023 ยท CAF Nebulizer (Direct Patient Interface)
MEDLINE INDUSTRIES, LP - Northfield
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
| Date | Sep 14, 2023 (initiated Aug 4, 2023) |
| Status | Open, Classified |
| Reason | Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers. |
| Root cause | Process control |
| Action | Medline issued a recall notice on 08/04/2023 to its consignees by mail and email. The notice explained the problem with the product, risk to use, and requested all affected product be destroyed. Distributors are directed to notify their customers and have the customers document and destroy any affected product. This should be included the customers quantities on the distributor response form. |
| Quantity | 18,000 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142153 | HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML Teleflexmedical, Inc., Apr 29, 2015 |