Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single
FDA device recall Z-0932-05 · posted 2005-06-25 · Terminated
Recall details
- Recalling firm
- Kendall Healthcare Products Co
- Reason for recall
- Holes in thermoformed tray compromising the sterility of the product.
- Action taken
- Visits by Tyco Sales Reps on 4/27 & 28/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 120 units
- Distribution
- Product shipped to hospitals in AZ, CA, IL, IN, NY, and TX.
- Date initiated
- 2005-04-27
- Date posted
- 2005-06-25
- Date terminated
- 2005-06-27
- Location
- Mansfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 (K042461) | Kendall | 2004-12-10 |