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

    Sterile Procedural Trays Recalled for Potential Blade Puncture of Packaging

    Medline Industries is recalling multiple sterile procedural trays because blades within the kits can potentially puncture the outer foil packaging, compromising sterility. The recall affects approximately 215,456 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROC
    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 (LS MS PACK) because the sterile blade inside can potentially puncture the outer packaging layer, compromising sterility.

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

    Sterile Procedural Trays Recalled Due to Potential Blade Packaging Puncture

    Medline Industries is recalling sterile procedural trays because blades within the kits may puncture the outer foil packaging, potentially compromising sterility.

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

    Sterile Trach Pack procedure kits recalled due to blade puncture risk

    Medline Industries is recalling TRACH PACK sterile procedure kits because sterile blades within the kits can puncture the outer foil packaging, potentially compromising product sterility.

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

    Sterile Surgical Trays Recalled for Potential Sterile Packaging Puncture

    Medline Industries recalls sterile surgical procedural trays because blades within the kits could puncture the sterile outer packaging, potentially compromising sterility during surgical use.

    Product
    Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Medline Sterile Procedural Trays Recalled for Packaging Puncture Risk

    Medline Industries is recalling ANCILLARY PACK-LF sterile procedural trays because sterile blades in the kits may puncture the outer foil layer of sterile packaging, potentially compromising the sterility of the contents.

    Product
    ANCILLARY PACK-LF. Sterile Procedural Tray.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Medline Sterile Surgical Trays Recalled for Potential Blade Puncture of Packaging

    Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWE
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Sterile arthroscopy trays recalled for potential blade puncture risk

    Medline Industries recalls multiple sterile arthroscopy surgical trays because blades in the kits may puncture the outer foil packaging, potentially compromising sterility. Affected products were distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Packaging Compromise

    Medline Industries recalls sterile pelviscopy trays because blades inside may puncture the protective foil packaging, potentially compromising sterility. 316 units distributed worldwide are affected.

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

    Medline Sterile Procedural Trays Recalled Due to Packaging Puncture Risk

    Medline recalls sterile procedural trays because blades may puncture the foil packaging, potentially compromising sterility. The recall affects over 227,000 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TO
    Category
    Distribution
    0 states
  • 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

    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 l
    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