Namic FLUID DELIVERY SET, REF 91300040
FDA device recall Z-1807-2024 · posted 2024-05-10 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Products have a lack of sterility assurance.
- Action taken
- Medline issued a Medical Device Recall notice to its consignees on 03/12/2024 via email and US Mail. The notice explained the issue, potential risk, and requested destruction of the affected product. Those who further distributed the product were directed to notify those to whom they shipped the product.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FPA
- Quantity affected
- 50 units
- Distribution
- US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.
- Date initiated
- 2024-03-12
- Date posted
- 2024-05-10
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS) (K852140) | North American Instrument Corp. | 1985-05-30 |