The Recall Desk

FDA (Devices) recall action 95528

Cook Incorporated recalled 2 products on 2024-11-20

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2024-11-20
Critical
0
Units
—

Why these products were recalled

Affected device lots have labels that state the incorrect expiration dates.

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

1–2 of 2

  • HighFDA (Devices)··2024-11-20

    Approach Hydro ST Micro Wire Guide Recalled for Incorrect Expiration Dates

    Cook Incorporated is recalling Approach Hydro ST Micro Wire Guide devices because affected device labels contain incorrect expiration dates. Using mislabeled devices beyond their actual expiration creates a risk of device failure and patient harm.

    Product
    Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-11-20

    Cook Approach CTO Micro Wire Guide recalled for incorrect expiration date labels

    Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates on affected lot labels. The recall affects 2,005 units in the US and 1,145 units overseas.

    Product
    Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
    Category
    Distribution
    0 states