The following brand name labeled products are under recall (all catalog numbers and all lot numbers under recall): NIPRO
FDA device recall Z-0408-03 · posted 2003-05-21 · Terminated
Recall details
- Recalling firm
- Nipro Corp
- Reason for recall
- Air or fluid leakage at the hub/needle junction.
- Action taken
- The recall letters were mailed on November 8, 2002 to direct accounts and requested subrecall down to the health professional/clinic level. It was requested that Nipro be notified of all held and recovered product for pickup. Also new replacement product will be made available in the near future.
- Root cause
- Other
- Status
- Terminated
- Product code
- FIE
- Quantity affected
- 6,984,000
- Distribution
- Nationwide and Canada
- Date initiated
- 2002-11-08
- Date posted
- 2003-05-21
- Date terminated
- 2008-04-15
- Location
- Miami, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIPRO SAFETOUCH SAFETY FISTULA NEEDLE (K002813) | Nipro Medical Corp. | 2000-11-21 |