HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
FDA device recall Z-2514-2023 · posted 2023-09-14 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- CAF
- Quantity affected
- 18,000 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-08-04
- Date posted
- 2023-09-14
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML (K142153) | Teleflexmedical, Inc. | 2015-04-29 |