The Recall Desk

FDA (Devices) recall action 64928

Baxter Healthcare Corp. recalled 4 products on 2015-09-02

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2015-09-02
Critical
0
Units
1,543,011

Why these products were recalled

Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.

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

1–4 of 4

  • ModerateFDA (Devices)··2015-09-02

    Baxter MiniCap Peritoneal Dialysis Transfer Set Labeling Recall

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets to update labeling with safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are perf
    Category
    Distribution
    5 states
  • ModerateFDA (Devices)··2015-09-02

    Baxter Recalls CAPD Solution Transfer Sets for Labeling Revisions

    Baxter Healthcare Corp. is recalling 35,460 units of CAPD Solution Transfer Sets to update labeling with additional safety instructions and warnings.

    Product
    CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.
    Category
    Distribution
    5 states
  • ModerateFDA (Devices)··2015-09-02

    Baxter MiniCap Extended Life PD Transfer Set Labeling Recall

    Baxter Healthcare Corp. is recalling 33,474 units of MiniCap Extended Life PD Transfer Sets to update labeling with additional safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer
    Category
    Distribution
    5 states
  • ModerateFDA (Devices)··2015-09-02

    Baxter Recalls MiniCap Peritoneal Dialysis Transfer Sets for Labeling Updates

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets to update labeling with new safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnect
    Category
    Distribution
    5 states