Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936
FDA device recall Z-0709-03 · posted 2003-04-03 · Terminated
Recall details
- Recalling firm
- I-Flow Corporation
- Reason for recall
- Wrong component may result in over infusion of medications.
- Action taken
- Recall was initiated by fax on March 5, 2003 and follow-up email on March 6, 2003. Firm is requesting returns of any unused product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 5,808 units
- Distribution
- States of NY and MA, and internationally to England, Spain, Mexico, Canada, Italy, Austrailia, South Africa.
- Date initiated
- 2003-03-05
- Date posted
- 2003-04-03
- Date terminated
- 2004-12-01
- Location
- Lake Forest, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS (K923875) | I-Flow Corp. | 1993-05-13 |