Recall Z-0932-05 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Kendall Healthcare Products Co
Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Firm on label: Tyco Healthcare, Mansfield, MA. Product sold sterile, 10 units per case.
| Date | Jun 25, 2005 (initiated Apr 27, 2005) |
| Status | Terminated |
| Reason | Holes in thermoformed tray compromising the sterility of the product. |
| Root cause | Other |
| Action | Visits by Tyco Sales Reps on 4/27 & 28/2005. |
| Quantity | 120 units |
| Distribution | Product shipped to hospitals in AZ, CA, IL, IN, NY, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042461 | KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 Kendall, Dec 10, 2004 |