Z-1463-2024Class II

Ureteral dilator, REF RBD014

Name: Z-1463-2024 Ureteral dilator, REF RBD014
Creator: Coloplast Manufacturing US, LLC
Published: 2024-03-11
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-03-11 / Open, Classified / root cause: packaging

FDA source

Coloplast Manufacturing US, LLC began a recall of Ureteral dilator, REF RBD014 on 2024-03-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1463-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-11
Posted: 2024-04-02
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Ureteral dilator, REF RBD014
Product code: EZN Dilator, Catheter, Ureteral
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.
Root cause tag: packaging
FDA root cause: 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: [email protected], 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1463-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1463-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-02

Product code EZN

K170531Class IIUreteral Dilators and Percutaneous Nephrostomy DilatorsColoplast Corp. / cleared 2017-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)