Recalls / —
—#97131
Product
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr/5 cm, CUDLMY501JPED- ABRM-HC-FST, G43982, 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-UDLMY-501J-PED-ABRM-HC-FST; Global Part Number G43982, lots 2243905, 2252486, 2254311, 2259321, 2263387, 2269786, 2275439, 2282402, 2284654, 2297817, 2303833, 2315324 2319566 and 2329777.
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 #97131. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.