CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable recall — FDA Z-0562-2019
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Overview of recall records associated with Civco Medical Instruments Co. Inc., including dates, categories and classifications where available.
Classification mix: Class II: 31.
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex…
CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5)…
CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
A cover failed leak testing during validation testing of new needle guides from a replacement tool.
This page summarizes recall records in which the official source identifies Civco Medical Instruments Co. Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.