CIVCO Medical Instruments Co., Inc.: The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.

Agency Publication Date: December 7, 2018

Affected Products

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.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

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.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

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.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

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.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

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.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

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.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

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..

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

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.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81361

Status: Resolved

Manufacturer: CIVCO Medical Instruments Co., Inc.

Manufactured In: United States

Units Affected: 15 products (738 boxes; 1,375 boxes; 948 boxes; 73 boxes; 297 boxes; 115 boxes; 257 boxes; 234 boxes; 66 boxes; 468 boxes; 613 boxes; 20 boxes; 49 boxes; 3 boxes; 135 boxes)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

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.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Product: CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81361

Status: Resolved

Manufacturer: CIVCO Medical Instruments Co., Inc.

Manufactured In: United States

Units Affected: 15 products (738 boxes; 1,375 boxes; 948 boxes; 73 boxes; 297 boxes; 115 boxes; 257 boxes; 234 boxes; 66 boxes; 468 boxes; 613 boxes; 20 boxes; 49 boxes; 3 boxes; 135 boxes)