Recall Z-0650-2013— California Medical Laboratories Inc
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: 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.. 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 recordK-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
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.
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.