The Recall Desk
HighFDA (Devices)·Z-1451-2024·Announced 2024-04-10

Centurion umbilical cord clamp cutter recalled for potential sterility breach

Medline's Centurion umbilical cord clamp cutters may have weak seals that could compromise sterility. The defect may not be detectable during normal inspection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with potential for sterility compromise in a neonatal use context. No reported illnesses or injuries. Per the rubric, this is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling 1350 units of the Centurion DISP.UMBILICAL CORD CLAMP CUTTER (CTR300, Product Code 67335). This is a single-use sterile medical device designed for use in umbilical cord management during childbirth.

The devices may have a weak seal that could result in a breach of sterility. The weak seal may not be detectable by users during visual inspection before use.

The recalled units were distributed worldwide, including throughout the United States, Panama, and Canada. The affected lot number is 2023111090.

Healthcare facilities and medical professionals who received these units should contact Medline Industries for instructions regarding the recall.

The recalled product

Product
Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Obstetrical
Hazard
  • weak-seal
  • sterility-breach

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 00653160349771 (case) 10653160349778 (each)
  • Lot Numbers: 2023111090

Distribution

Distributed nationwide across the United States.

Related recalls

Same category