Recall Z-0649-2013— California Medical Laboratories Inc

Name: FDA recall Z-0649-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-02

Class II · Terminated

Class II FDA medical device recall by California Medical Laboratories Inc, initiated 2012-11-02, terminated 2013-03-04. It names one FDA 510(k) clearance: K982891. Product: Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.. Reason: 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..

Recalling firm: California Medical Laboratories Inc
Classification: Class II
Status: Terminated
Initiated: 2012-11-02
Terminated: 2013-03-04
Firm location: Costa Mesa, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K982891 — CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDSCalifornia Medical Laboratories, Inc.·cleared 1998-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.