All Med Medical 20ga x .75" Winged Administration Set Model # M2075 Reorder # 50-2021
FDA device recall Z-2515-2010 · posted 2010-09-29 · Terminated
Recall details
- Recalling firm
- Multi-Med, Inc.
- Reason for recall
- Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Action taken
- Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 43,404 units
- Distribution
- Worldwide Distribution -- USA and Mexico.
- Date initiated
- 2010-08-30
- Date posted
- 2010-09-29
- Date terminated
- 2013-01-31
- Location
- Keene, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRAVASCULAR ADMINISTRATION SET (K891919) | Multi-Med, Inc. | 1989-05-05 |