Recalls / —
—#96997
Product
Peripherally Inserted Central Venous Catheter Tray Silicone, CPICSY401HOPKINS0911 00, G13169, 4.0 Fr/60cm, Sterile, Cook Incorporated, 750 Daniels Way, Bloomington, IN 47404 , USA
- FDA product code
- LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- Affected lot / code info
- Part Number: C¿PICSY¿401¿HOPKINS¿0911 00; Global Part Number 13169; Lot: F2349680.
Why it was recalled
Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes that have been recalled by Excelsior Medical. During a routine test for syringe sterility, a possible integrity failure wa
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Recalling firm
- Firm
- Cook, Inc.
- Address
- 750 Daniels Way, Bloomington, Indiana 47404-9120
Distribution
- Distribution pattern
- Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
Timeline
- Recall initiated
- 2010-10-04
- Posted by FDA
- 2011-02-23
- Terminated
- 2011-06-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #96997. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.