The Recall Desk

FDA (Devices) recall action 65183

Baxter Healthcare Corp. recalled 3 products on 2013-07-17

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
2013-07-17
Critical
0
Units
1,136,792

Why these products were recalled

A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.

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)··2013-07-17

    Baxter Recalls Four Lead TUR Irrigation Sets Due to Packaging Pinholes

    Baxter Healthcare is recalling 356,728 units of Four Lead TUR irrigation sets because pinholes in the packaging could compromise sterile barrier properties.

    Product
    Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-07-17

    Baxter Recalls Arthroscopic Irrigation Sets Due to Packaging Pinholes

    Baxter Healthcare Corp. is recalling Four Lead Arthroscopic Irrigation Sets because pinholes in the packaging could compromise sterile barrier properties.

    Product
    Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-07-17

    Baxter Arthroscopic Irrigation Sets Recalled Due to Packaging Pinholes

    Baxter Healthcare is recalling Two Lead Arthroscopic Irrigation Sets because pinholes in the packaging could compromise sterile barrier properties.

    Product
    Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during…
    Category
    Distribution
    0 states