FDA-Device2013-01-16Class II
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
California Medical Laboratories Inc
Hazard
California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Sold states
Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.
Affected count
S112468N=1000 units, S120196N=1400 units, & S120197N=1200 units
Manufactured in
1570 Sunland Ln, Costa Mesa, CA, United States
Products
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0650-2013Don't want to check this manually?
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