The Recall Desk
HighFDA (Devices)·Z-3119-2024·Announced 2024-09-18

Medline Surgical Suction Kits Recalled for Potential Loss of Suction

Medline Industries recalls specific lots of semi-rigid suction liners in C-section convenience kits due to reported adverse events. The liners may lose suction during intermittent use.

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 a Class II medical device with reported adverse events involving loss of critical function during surgical use. Although adverse events were reported, the source does not specify hospitalization or documented serious injuries, meeting the criterion for High rather than Severe severity.

Plain-English summary

Medline Industries, LP is recalling specific lots of semi-rigid suction liners included in MERCY TIFFIN C-Section convenience kits (Pack Number DYNJ909732). The affected lot numbers are 23LBT911, 24ABX052, and 24CBE496, totaling 35 units. The liners were manufactured between September and November 2023.

The recall was initiated due to reported adverse events involving the potential loss of suction or low suction during intermittent suction use. This malfunction could affect the device's intended performance during surgical procedures.

The affected products were distributed worldwide, including throughout the United States, Canada, and Panama. Healthcare facilities and surgical centers that received these specific lot numbers may have the affected kits in inventory.

Clinical staff and healthcare facilities should verify the lot numbers of any MERCY TIFFIN C-Section convenience kits in their inventory and stop using the affected lots. Contact Medline Industries, LP for instructions on replacement, return, or reporting of any adverse events.

The recalled product

Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number DYNJ909732
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • loss-of-suction
  • medical-device-malfunction

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 (5)

  • DYNJ909732: UDI/DI case 4019532746469240195327464746
  • UDI/DI each 10195327464745
  • Lot Numbers: 23LBT911
  • 24ABX052
  • 24CBE496

Distribution

Distributed nationwide across the United States.