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Issue Health Canada is advising patients who use MiniCap Extended Life Peritoneal Dialysis Transfer Sets, manufactured by Baxter Corporation, that direct contact between the sets and certain cleaning products, including hand sanitizers and solvents, may damage the sets. The company has also informed Health Canada that it has notified all affected customers health care facilities , and will update the product Instructions for Use to warn that use of the following products should be avoided on the transfer sets: hand sanitizers and cleaning products that contain hydrogen peroxide, bleach, alcohol or antiseptic agents; and solvents intended to remove adhesive residue, such as those containing acetone, toluene, xylene, or cyclohexanone The Department is monitoring the effectiveness of this corrective action and will inform Canadians if any new health risks are identified.
What you should do Avoid direct contact between the transfer sets and the following cleaning products: hand sanitizers and cleaning products that contain hydrogen peroxide, bleach, alcohol or antiseptic agents; and solvents intended to remove adhesive residue, such as those containing acetone, toluene, xylene or cyclohexanone. If your transfer set is damaged e.
Consult your health care provider with any questions or concerns about your transfer set. Seek immediate medical attention if you experience symptoms of peritonitis. Use proper cleaning practices to clean the device, as outlined in the Instructions for Use or as directed by a health care professional. You may also contact Baxter Corporation at if you have questions about this issue or about your transfer set.
Report any health product-related complaints to Health Canada. Additional information Details Original published date: Published by. Health Canada.
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E-mail adress. Medsun Reports. New Search. Date Initiated by Firm January 07, Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
Baxter disseminated a Urgent Medical Device Correction letter on 7 January to peritoneal dialysis centers and will follow with notice to the patients on 12 January The notices warned that the use of cleaning products and solvents may cause damage for example, leaking or cracking , if they come into direct contact with the transfer set.
Baxter will be updating the Instructions for Use IFU to include a warning against the use of these cleaning products and solvents. For general questions regarding this communication, contact Baxter Corporate Product Surveillance at The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated.
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WebDec 17, аи PD Transfer Set Change Kit (10 sterile gauze, catheter or beta clamp, 30 ml soaking tray, 2 face masks with ear loop, 3 pairs of sterile gloves, 2 poly-lined towels for . WebPD Holder that keeps your Transfer Set safe and secure, without hindering your body movements or causing any discomfort. Lanyard length 21 inches. Secure way to hold . WebJan 7, аи Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C Code Information: All lot numbers within expiry: Recalling Firm/ .