The Recall Desk

FDA (Devices) recall action 91457

MEDLINE INDUSTRIES, LP - Northfield recalled 3 products on 2023-03-01

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2023-03-01
Critical
0
Units
6,769

Why these products were recalled

The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2023-03-01

    Medline Sterile Hand Pack recalled for inadequate sterilization

    Medline Sterile Hand Pack surgical prep kits are recalled because components were improperly placed in the nonsterile portion of the tray and did not receive proper sterilization. Affects 1,689 trays distributed in AR, CO, and GA.

    Product
    (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and (2) Medline Sterile Hand Pack, Item DYNJ63380C, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor P
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2023-03-01

    Medline Sterile Maximum Barrier Pack-LF units recalled for sterilization failure

    Medline Industries recalls approximately 720 Sterile Maximum Barrier Pack-LF units due to improper component placement preventing sterilization. The affected packs were distributed in Arkansas, Colorado, and Georgia.

    Product
    (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546D, 6 kits per case, contains BD Chloraprep Hi-Lite Oran
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2023-03-01

    Sterile Oncology Port Access Tray Recalled for Sterilization Failure

    Medline is recalling sterile oncology port access trays in which some components were not properly sterilized due to improper placement during manufacturing. Healthcare facilities should immediately discontinue use of affected units.

    Product
    Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
    Category
    Distribution
    3 states