The Recall Desk
HighFDA (Devices)·Z-3107-2024·Announced 2024-09-18

Medline Surgical Suction Liners Recalled for Potential Loss of Suction

Medline Industries is recalling 1,646 units of semi-rigid suction liners used in surgical kits due to reported adverse events involving potential loss of suction or low 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 an FDA Class II recall of surgical suction liners initiated due to reported adverse events involving potential loss of suction during use. The potential malfunction of critical surgical equipment during procedures poses a risk of patient harm, warranting a High severity classification.

Plain-English summary

Medline Industries, LP is recalling 1,646 units of semi-rigid suction liners used in six types of surgical convenience kits, manufactured between September and November 2023. Affected kit types include Open Heart, Endo, Vascular-LF, Major Cardiovascular Adult, and AV Fistula kits, identified by pack numbers DYK1002174I, DYKE1558B, DYKE1804A, DYNJ900714C, DYNJ905472B, and DYNJ908096A with corresponding lot numbers specified by the FDA.

The recall was initiated due to reported adverse events involving potential loss of suction or low suction during intermittent suction use. This malfunction could impact the performance of the suction liners during surgical procedures.

The affected kits have been distributed worldwide including the United States, Canada, and Panama. Healthcare facilities and medical institutions using these Medline surgical convenience kits should verify their inventory against the recalled pack and lot numbers.

Facilities with affected kits should contact Medline Industries for guidance on return, replacement, or proper disposal of the recalled products. The FDA recall number is Z-3107-2024.

The recalled product

Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR CARDI
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Supplies
Hazard
  • suction-loss

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) DYK1002174I: UDI/DI case 40195327332403
  • UDI/DI each 10195327332402
  • Lot Numbers: 24CLA959
  • b) DYKE1558B: UDI/DI case 40195327258512
  • UDI/DI each 10195327258511
  • Lot Numbers: 24DMA783
  • 24BMG878
  • 23LMG790
  • c) DYKE1804A: UDI/DI case 40195327023035
  • UDI/DI each 10195327023034
  • Lot Numbers: 24BMI437
  • 24AME311
  • 23LMC958
  • d) DYNJ900714C: UDI/DI case 40193489951364
  • UDI/DI each 10193489951363
  • Lot Numbers: 24FBC609
  • e) DYNJ905472B: UDI/DI case 40195327200573
  • UDI/DI each 10195327200572
  • Lot Numbers: 24BBS291
  • f) DYNJ908096A: UDI/DI case 40195327507061

Distribution

Distributed nationwide across the United States.

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