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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Event Detail

Event ID 63896
Product Type Devices
Status Ongoing
Recalling Firm California Medical Laboratories Inc
City Costa Mesa
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-02
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field. Catalog No: SU-12202 Lot No: S112462, S111480 Class II 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. S112462=995 units & S111480 1430 units Z-0649-2013
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. Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N Class II 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. S112468N=1000 units, S120196N=1400 units, & S120197N=1200 units Z-0650-2013
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