MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, MX20443: LogiCal Single Pressure Kit, MX20470: Pressure Monitoring
FDA device recall Z-0198-05 · posted 2004-11-16 · Terminated
Recall details
- Recalling firm
- Medex Inc
- Reason for recall
- Sampling port bodies on the device are cracking which can allow the sampling site to become dislodged from the body.
- Action taken
- The firm sent certified letters on October 20 & 21, 2004 to all customers to whom the product was sent directly and to all distributors to whom Medex shipped the product directly in the United States. Customers in foreign countries were notified via Fed Ex.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 71,132 units.
- Distribution
- The product was distributed throughout the United States to distributors and hospitals located in FL, PA, CA, NE, SC, NY, MO, NM, GA, IL, MN, NC, Washington DC, RI, CO, MS, WI, HI, TX, MI, VA, WA, NJ,
- Date initiated
- 2004-10-20
- Date posted
- 2004-11-16
- Date terminated
- 2012-04-11
- Location
- Dublin, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTERIAL BLOOD SAMPLING KIT (K902771) | Medex, Inc. | 1990-11-05 |