The Recall Desk
HighFDA (Devices)·Z-3115-2024·Announced 2024-09-18

Medline Semi-Rigid Suction Liners Recalled Due to Loss of Suction

Medline is recalling 444 NICU admit kits containing semi-rigid suction liners due to potential loss or low suction during intermittent use. Affected units were distributed in the US, Canada, and Panama.

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: This is an FDA Class II recall for a medical device with reported adverse events related to loss of suction functionality. The source does not provide specific details on hospitalizations or injuries, which would be required for a Severe classification. The potential loss of suction represents a risk-of-harm in a critical care setting, meeting the criteria for High.

Plain-English summary

Medline Industries, LP is recalling 444 units of NICU admit kits containing semi-rigid suction liners (Pack Number DYKA1014G, lot numbers 24ABD771 and 24BBT444), manufactured between September and November 2023.

The recall was issued due to reported adverse events associated with a potential loss of suction or low suction during intermittent suction use.

The affected units were distributed worldwide, including across the United States, Canada, and Panama. Healthcare facilities should verify whether they have inventory matching the specified lot numbers.

The recalled product

Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • loss-of-suction
  • equipment-failure

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 (4)

  • DYKA1014G: UDI/DI case 40195327446858
  • UDI/DI each 10195327446857
  • Lot Numbers: 24ABD771
  • 24BBT444

Distribution

Distributed nationwide across the United States.