The Recall Desk

FDA (Devices) recall action 71911

International Biophysics Corp. recalled 3 products on 2015-08-26

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
2015-08-26
Critical
0
Units
11,201

Why these products were recalled

It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

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.

1–3 of 3

  • ModerateFDA (Devices)··2015-08-26

    International Biophysics Recalls IBC Suction Wands Due to Seal Defects

    International Biophysics Corp. is recalling 100 IBC Suction Wands because heat seals on sterile pouches may not meet strength criteria.

    Product
    IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-08-26

    International Biophysics Corp. Recalls IBC Vascular Loops Due to Seal Issues

    International Biophysics Corp. is recalling 771 IBC Vascular Loops because heat seals on sterile pouches may not meet strength criteria.

    Product
    IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-08-26

    International Biophysics Recalls IBC Aortic Punch Due to Seal Issues

    International Biophysics Corp. is recalling 10,330 units of IBC Aortic Punch because the heat seal on sterile pouches may not meet strength acceptance criteria.

    Product
    IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a…
    Category
    Distribution
    0 states