The Recall Desk

Manufacturer

AccessClosure, Inc., A Cardinal Health Company

2 recalls in our database name AccessClosure, Inc., A Cardinal Health Company as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2016-11-02

Of the 2 recalls from AccessClosure, Inc., A Cardinal Health Company we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-0297-2017·2016-11-02

    AccessClosure Recalls PAXWIRE Occlusion Balloon System Due to Removal Risk

    AccessClosure, Inc. is voluntarily recalling the PAXWIRE Occlusion Balloon System because the device may be removed without a vascular sheath in place.

    Product
    The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during cathete
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2329-2016·2016-08-10

    AccessClosure Recalls MynxGrip Vascular Closure Devices Due to Packaging Errors

    AccessClosure is recalling 70 MynxGrip Vascular Closure Devices shipped with improper transport and packaging configurations.

    Product
    6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have underg
    Category
    Medical Device
    Distribution
    2 states