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.
FDA Recall Z-0932-05 · Posted 2005-06-25
Recalling FirmKendall Healthcare Products Co
Recall StatusTerminated
Product CodeLJS
Date Initiated2005-04-27
Date Terminated2005-06-27
Product Quantity120 units
Reason for Recall
Holes in thermoformed tray compromising the sterility of the product.
Firm Action
Visits by Tyco Sales Reps on 4/27 & 28/2005.
Root Cause
Other
Distribution Pattern
Product shipped to hospitals in AZ, CA, IL, IN, NY, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.