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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter MiniCap Extended Life PD Transfer Set

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 Class 2 Device Recall Baxter MiniCap Extended Life PD Transfer Setsee related information
Date Initiated by FirmJanuary 07, 2022
Create DateFebruary 08, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0573-2022
Recall Event ID 89327
510(K)NumberK152675 
Product Classification Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
ProductBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
Code Information All lot numbers within expiry
FEI Number 1417572
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Other
ActionBaxter disseminated a Urgent Medical Device Correction letter on 7 January 2022 to peritoneal dialysis centers and will follow with notice to the patients on 12 January 2022. 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 800-437-5176.
Quantity in Commerce61,290 units
DistributionWorldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. 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. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KDJ
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