RecallDepth

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.

Company
Kendall Healthcare Products Co
Recall Initiated
April 27, 2005
Posted
June 25, 2005
Terminated
June 27, 2005
Recall Number
Z-0932-05
Quantity
120 units
Firm Location
Mansfield, MA

Reason for Recall

Holes in thermoformed tray compromising the sterility of the product.

Distribution

Product shipped to hospitals in AZ, CA, IL, IN, NY, and TX.

Lot / Code Info

158125 and 158128

Root Cause

Other

Action Taken

Visits by Tyco Sales Reps on 4/27 & 28/2005.

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