Recall Z-0563-2019— 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: SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.. 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
SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.
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.