The Recall Desk

FDA (Devices) recall action 91386

MEDLINE INDUSTRIES, LP - Northfield recalled 38 products on 2023-02-15

The FDA (Devices) publishes a recall like this one as 38 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 38 pages.

Products
38
Announced
2023-02-15
Critical
0
Units
—

Why these products were recalled

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

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

26–38 of 38

  • HighFDA (Devices)··2023-02-15

    Medline Sterile Procedural Trays Risk Package Puncture and Sterility Compromise

    Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer foil packaging, potentially compromising sterility. The recall affects 858 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Sterile Surgical Trays Recalled for Blade Puncture of Packaging

    Medline Industries is recalling sterile surgical trays used in plastic and reconstructive surgery because blades within the kits can puncture the outer foil packaging, potentially compromising sterility. Approximately 15,009 units were distributed nationwide and internationally.

    Product
    Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Packaging Puncture

    Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer packaging foil, potentially compromising sterility. No injuries have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Blade Puncture of Packaging

    Medline Industries recalls sterile procedural trays (Wound Closure Tray and Wound Pack) distributed worldwide because sterile blades may puncture the outer foil packaging.

    Product
    Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Medline Sterile Surgical Trays Recalled Due to Blade Puncture Risk

    Medline Industries recalls sterile surgical procedural trays because sterile blades within the kits may puncture the outer foil packaging, potentially compromising sterility. No injuries or illnesses have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Sterile surgical trays recalled due to packaging puncture risk

    MEDLINE INDUSTRIES is recalling six models of sterile surgical trays due to a potential for blades within the kits to puncture the sterile packaging. Affected trays were distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Sterile Procedural Trays With Blades That May Puncture Packaging

    Medline recalls sterile surgical trays because internal blades can puncture the outer protective foil packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i. C-SECTION CDS-LF j. C-SECTION CDS k. C-SECTION CDS l.…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the protective foil packaging. Approximately 12,964 cases (23,379 units) distributed worldwide are affected.

    Product
    Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Sterile Procedural Trays Recalled for Potential Blade Puncture

    Medline sterile procedural trays for minor and breast biopsies are being recalled because sterile blades may puncture the outer foil packaging, compromising sterility. The recall affects 237 cases (1,242 units) distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Medline Sterile Procedural Trays Recalled for Potential Blade Puncture in Packaging

    Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer foil sterile packaging, compromising sterility. No injuries have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Sterile Procedural Trays Recalled Over Potential Blade Puncture of Packaging

    Medline Industries is recalling sterile procedural trays because sterile blades inside could puncture the outer foil packaging, compromising sterility. The recall affects units distributed worldwide.

    Product
    UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling sterile procedural trays (ENDOSCOPY-LF and SEPTO/ENDO) because sterile blades may puncture the outer foil layer of the sterile packaging. The recall affects units distributed nationwide and internationally.

    Product
    Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
    Category
    Distribution
    0 states