Recalls / —
—#97209
Product
Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20cm, C-UTLMY-701J-RSC-CCT-RD, G47822, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
- FDA product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K081113
- Affected lot / code info
- Part number: C-UTLMY-701J--RSC-CCT-RD, Global part number G47822 Lot number: 2237550, 2238016, 2240456, 2248191, 2253955, 2272121 2317013, 2318898 and 2322733.
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 #97209. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.