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U.S. Department of Health and Human Services

Class 2 Device Recall Stay Safe Cap

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  Class 2 Device Recall Stay Safe Cap see related information
Date Initiated by Firm October 10, 2023
Date Posted December 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-0507-2024
Recall Event ID 93396
510(K)Number K083542  
Product Classification Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
Product Stay Safe Cap
Code Information Model No. 050-95012; UDI-DI: 00840861100835; All Lots.
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 920
Waltham MA 02451-1521
For Additional Information Contact Global medical information and Education Office
1-855-616-2309
Manufacturer Reason
for Recall		 Updating the labeling to include additional warnings and contraindications for potential side effects.
FDA Determined
Cause 2		 Labeling design
Action Consignees were mailed an IMPORTAND MEDICAL DEVICE INFORMATION notification dated 10/10/23 vis USPS. This notification is to bring awareness to consignees that Fresenius is updating the labeling to their Stay Safe Cap to include additional warnings and contraindications for potential side effects for P/N 05-95012. Increased exposure to povidone-iodine, which is present in the Stay Safe Cap, could lead to iodine-induced hypothyroidism and hypersensitivity. Clinicians are asked to not use these devices in known cases of povidone-iodine allergy. Fresenius is updating labeling to include these medical warnings and contraindications. Any clinical or medical questions can be directed to the firm at 1-855-616-2309. Consignees are asked to return the provided Reply Form by fax to 781-966-9796 or 781-472-7413, ATTN: Quality Department, or by email to NOTIFYRA@fmc-na.com.
Quantity in Commerce 18,236,160 eaches
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KDJ and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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