FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline intermittent latex catheter recalled for connector detachment and surface defects

OTHERNationwide distributionMedical devices

What this means

Medline identified that samples of their 16 Fr intermittent latex catheter with pre-connected collection bag did not meet quality standards. The issues include rough spots on the catheter surface, connectors that may detach prematurely from the catheter, and in some cases, the catheter diameter being out of specification.

  • Check if you have Medline product number URO4RR16C (any lot number)
  • Stop using the affected catheter and contact Medline or your healthcare provider for a replacement
  • Report any problems with the catheter to Medline and the FDA
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The agency's original wording
Hazard

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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Affected count
10980 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2484-2026

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