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U.S. Department of Health and Human Services

Class 2 Device Recall Ureteral Dilator

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  Class 2 Device Recall Ureteral Dilator see related information
Date Initiated by Firm March 11, 2024
Date Posted April 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-1463-2024
Recall Event ID 94218
510(K)Number K170531  
Product Classification Dilator, catheter, ureteral - Product Code EZN
Product Ureteral dilator, REF RBD014
Code Information UDI-DI: 03600040300503, Lot codes: 6885096, 6928493, 7036982, 7092593, 7148682, 7187751, 7275918, 7326750, 7362229, 7405815, 7424892, 7440816, 7459583, 7528743, 7575957, 7742150, 7806993, 7825256, 7874646, 7948615, 8050730, 8122897, 8174950, 8210399, 8313229, 8350283, 8359041, 8442175, 8519426, 8619976, 8700201, 8864944, 8946228, 8946264, 9122793, 9122794, 9168554, 9226390, 9246177, 9360599
Recalling Firm/
Manufacturer		 Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis MN 55411-3431
For Additional Information Contact Coloplast Customer Service
800-258-3476
Manufacturer Reason
for Recall		 A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
FDA Determined
Cause 2		 Under Investigation by firm
Action Coloplast issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice to its consignees on 03/11/2024 via USPS first class mail. The notice explained the issue and requested the consignee contact the firm ( Email: urology@coloplast.com, Phone: 800-258-3476) for a refund for returned product.
Quantity in Commerce 710 units
Distribution US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
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 = EZN and Original Applicant = Coloplast Corp
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