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 CARDIOVASC ADULT, Pack Number DYNJ905472B; f) AV FISTULA, Pack Number DYNJ908096A

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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, UDI/DI each 10195327507060; Lot Numbers: 24ABX948, 24ABB080
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall:
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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 CARDIOVASC ADULT, Pack Number DYNJ905472B; f) AV FISTULA, Pack Number DYNJ908096A

Product Codes/Lot Numbers:

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, UDI/DI each 10195327507060; Lot Numbers: 24ABX948, 24ABB080

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3107-2024

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