Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for
FDA device recall Z-2525-2015 · posted 2015-09-01 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Sterility may be compromised
- Action taken
- Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- NGT
- Quantity affected
- 207,876
- Distribution
- US Nationwide Distribution
- Date initiated
- 2015-08-06
- Date posted
- 2015-09-01
- Date terminated
- 2017-06-29
- Location
- North Haven, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY (K060339) | Tyco Healthcare/Kendall | 2006-04-28 |