Events

Recall of MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST CLAMP EXTRA LONG

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64991
  • Event Risk Class
    II
  • Event Initiated Date
    2014-12-24
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Baxter is sending an important safety update to the instructions for use for baxter peritoneal dialysis (pd) transfer sets titanium adapters disconnect caps and connection shield product codes. specifically baxter is adding contraindication statements to address iodine allergy for baxter's pd products which contain iodine (i.E. povidone iodine) or for which iodine use is recommended. there is no product hold or physical removal of devices from the field associated with this action.

Device

MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST CLAMP EXTRA LONG
  • Model / Serial
    Model Catalog: R5C4484 (Lot serial: H09K16070); Model Catalog: R5C4484 (Lot serial: H11F15077); Model Catalog: R5C4484 (Lot serial: H12F14061); Model Catalog: R5C4484 (Lot serial: H13E14047); Model Catalog: R5C4484 (Lot serial: H13J10020); Model Catalog: R5C4484 (Lot serial: H13L13046); Model Catalog: SPC4466 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: SPC4213 (Lot serial: 12D28H10); Model Catalog: SPC4213 (Lot serial: 12G24H10); Model Catalog: SPC4211 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: SPC4213 (Lot serial: 10B11H12); Model Catalog: SPC4213 (Lot serial: 11D01H10); Model Catalog: SPC4213 (Lot serial: 14G07H10); Model Catalog: SPC4486 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    MINICAP EXT LIFE PD TRANSTWISTXLONG
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION