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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Kendall Healthcare Products Co
Lot Codes / Batch Numbers
158125 and 158128
Products Sold
158125 and 158128
Kendall Healthcare Products Co is recalling Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, due to Holes in thermoformed tray compromising the sterility of the product.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Holes in thermoformed tray compromising the sterility of the product.
Recommended Action
Per FDA guidance
Visits by Tyco Sales Reps on 4/27 & 28/2005.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, IL, IN, NY, TX
Page updated: Jan 10, 2026