FDA (Devices) recall action 81361

CIVCO Medical Instruments Co., Inc. recalled 15 products on 2018-12-19

The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.

Products: 15
Announced: 2018-12-19
Critical: 0
Units: 5,391

Why these products were recalled

The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–15 of 15

ModerateFDA (Devices)··2018-12-19
CIVCO Needle Guide Starter Kit Recalled for Labeling Defects
CIVCO Medical Instruments is recalling 613 boxes of Needle Guide Starter Kits due to missing product labeling on reusable brackets.
Product
CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..
Category
Distribution
0 states
ModerateFDA (Devices)··2018-12-19
CIVCO Biopsy Bracket Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 73 boxes of Biopsy Brackets because some units lack required product labeling.
Product
CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-12-19
CIVCO Needle Guide Bracket Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 3 boxes of Needle Guide Brackets because some units lack required product labeling. The recall covers specific lot numbers and inventory without labels.
Product
CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-12-19
CIVCO Needle Guide Starter Kit Recalled Due to Missing Product Labeling
CIVCO Medical Instruments is recalling 468 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.
Product
CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-12-19
CIVCO Recalls SonoSite Needle Guide Brackets Due to Labeling Defects
CIVCO Medical Instruments is recalling 297 boxes of SonoSite Needle Guide Brackets because some units lack required product labeling.
Product
SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-12-19
CIVCO Needle Guide Starter Kit Recalled for Labeling Defects
CIVCO Medical Instruments is recalling 66 boxes of Needle Guide Starter Kits because some brackets lack required product labeling. The recall covers units distributed globally.
Product
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) for use with SonoSite L25 series transducers, 22 GAUGE, Rx.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-12-19
CIVCO Needle Guide Starter Kit Recalled for Labeling Defects
CIVCO Medical Instruments is recalling 20 boxes of Needle Guide Starter Kits due to missing product labeling. The voluntary recall covers units distributed in the US and 40 foreign countries.
Product
CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-12-19
CIVCO Needle Guide Bracket Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 49 boxes of Needle Guide Brackets because some units lack required product labeling.
Product
CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-12-19
CIVCO Recalls SonoSite FUJIFILM Needle Guide Brackets for Labeling Issues
CIVCO Medical Instruments is recalling 115 boxes of SonoSite FUJIFILM Needle Guide Brackets due to missing product labeling. The recall covers units distributed in the US and 40 foreign countries.
Product
SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:
Category
Distribution
0 states
ModerateFDA (Devices)··2018-12-19
CIVCO Needle Guide Starter Kit Recalled for Labeling Defects
CIVCO Medical Instruments is recalling 234 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.
Product
CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-19
CIVCO Needle Guide Bracket Recalled for Puncture Risk
CIVCO Medical Instruments is recalling 738 boxes of Needle Guide Brackets because they may puncture the sterile cover during assembly.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-12-19
CIVCO Needle Guide Starter Kit Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 257 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.
Product
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 covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-19
CIVCO Recalls SonoSite L25 Bracket Kits Due to Puncture Risk
CIVCO Medical Instruments is recalling SonoSite L25 Bracket Kits because the needle guide bracket may puncture the sterile cover during assembly.
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2018-12-19
CIVCO Sales Demo Kit Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 135 boxes of Sales Demo Kits because some inventory brackets no longer have product labeling.
Product
CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-19
CIVCO Needle Guide Bracket Recalled for Puncture Risk
CIVCO is recalling Needle Guide Brackets that may puncture the sterile cover during assembly, potentially compromising sterility.
Product
CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
Category
Distribution
0 states