Recall Z-0562-2019— CIVCO Medical Instruments Co., Inc.
Class II · Terminated
Class II FDA medical device recall by CIVCO Medical Instruments Co., Inc., initiated 2018-11-02, terminated 2020-11-20. It names one FDA 510(k) clearance: K030064. Product: CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.. Reason: The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly..
- Recalling firm
- CIVCO Medical Instruments Co., Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-02
- Terminated
- 2020-11-20
- Firm location
- Coralville, IA, 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
CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
Reason for recall
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.