The Recall Desk
HighFDA (Devices)·Z-3110-2024·Announced 2024-09-18

Medline Semi-Rigid Suction Liners Recalled for Potential Loss of Suction

Medline Industries is recalling specific convenience kits with semi-rigid suction liners due to reported adverse events and potential loss of suction during intermittent use. Affected: 358 units distributed in 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 a risk-of-harm medical device with reported adverse events affecting its critical function during use. Although the source does not specify details of injuries or hospitalizations, the existence of adverse events prompting a Class II recall and the device's role in surgical procedures where suction loss could impair critical function justifies a High severity rating.

Plain-English summary

Medline Industries, LP is recalling specific convenience kits containing semi-rigid suction liners. The affected products are identified by ten different package numbers and specific lot numbers, totaling 358 units manufactured between September 2023 and November 2023.

Due to reported adverse events, these liners may experience potential loss of suction or low suction when used for intermittent suction applications. This functional defect could impair the device's performance during medical procedures.

The recalled kits have been distributed worldwide, including across the United States, Canada, and Panama. Healthcare facilities and practitioners using these specific convenience kits should verify their inventory against the affected lot numbers listed in the recall notice.

Healthcare providers in possession of the recalled products should contact Medline Industries for instructions on returns or replacements and ensure affected units are removed from service.

The recalled product

Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J; c) OR MAJOR CDS, Pack Number CDS981515D; d) MAJOR-LF, Pack Number DYNJ900709C; e) MAJOR-LF, P
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Suction Liners
Hazard
Affected units
358

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 (20)

  • a) CDS981509C: UDI/DI case 40195327071173
  • UDI/DI each 10195327071172
  • Lot Numbers: 24ABS277
  • b) CDS981512J: UDI/DI case 4019532759782610195327597825
  • Lot Numbers: 24BBP412
  • c) CDS981515D: UDI/DI case 4019532707196810195327071967
  • Lot Numbers: 23KDC374
  • 24CDB523
  • 24EDA579
  • d) DYNJ900709C: UDI/DI case 4019348995099210193489950991
  • Lot Numbers: 23LBU953
  • e) DYNJ900709D: UDI/DI case 4019532763531310195327635312
  • Lot Numbers: 24CBQ684
  • f) DYNJ900723C: UDI/DI case 4019348995162310193489951622
  • Lot Numbers: 24ABL637
  • g) DYNJ900723D: UDI/DI case 4019532763534410195327635343
  • Lot Numbers: 24CBG030
  • 24CBO759
  • 24EBJ696
  • h) DYNJ908098A: UDI/DI case 4019532750725210195327507251

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

See all →

Same hazard · suction loss

See all →