Enforcement Report - Week of January 16, 2013
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Product Detail
| Product Description | Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field. |
|---|---|
| Recall Number | Z-0649-2013 |
| Classification | Class II |
| Code Info | Catalog No: SU-12202 Lot No: S112462, S111480 |
| Product Distributed Qty | S112462=995 units & S111480 1430 units |
| Reason For Recall | 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. |
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. |
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