FDA Medical Device Recalls (openFDA)
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 number
- Z-0932-05
- Recalling firm
- Kendall Healthcare Products Co
- 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.
- Status
- Terminated
- Initiated
- 2005-04-27
- Posted
- 2005-06-25
- Terminated
- 2005-06-27
- 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.
- Lot, serial or model codes
- 158125 and 158128
- 510(k) numbers
- ["K042461"]
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28