FDA Enforcement
Class II
Ongoing
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C
Recall: Z-2484-2026
·
Reported June 24, 2026
Enforcement
- Recall Number
- Z-2484-2026
- Event ID
- 98994
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- June 24, 2026
- Initiation Date
- May 4, 2026
- Classification Date
- June 17, 2026
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C
Reason
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Code Info
UDI/DI 10197344149001 (each), 20197344149008 (case); ALL LOTS
Distribution
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Quantity
10980 units