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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