The Recall Desk

FDA (Devices) recall action 80727

Bayer Medical Care, Inc. recalled 3 products on 2018-09-12

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2018-09-12
Critical
0
Units
7

Why these products were recalled

The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.

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.

States named across these recalls

1–3 of 3

  • SevereFDA (Devices)··2018-09-12

    Bayer Overhead Counterpoise Systems Recalled for Potential Structural Failure

    Bayer Medical Care is recalling one Overhead Counterpoise System unit due to potential overtightening of bolts that could compromise structural integrity.

    Product
    Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288
    Category
    Distribution
    3 states
  • SevereFDA (Devices)··2018-09-12

    Bayer Medical Care Recalls Overhead Counterpoise Systems Due to Structural Risk

    Bayer Medical Care is recalling four Overhead Counterpoise Systems because overtightened bolts may compromise structural integrity, posing a risk of injury.

    Product
    Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
    Category
    Distribution
    3 states
  • SevereFDA (Devices)··2018-09-12

    Bayer Overhead Counterpoise Systems Recalled for Potential Structural Failure

    Bayer Medical Care is recalling two Overhead Counterpoise Systems because overtightened bolts may compromise structural integrity, posing a risk of injury.

    Product
    Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
    Category
    Distribution
    3 states