The Recall Desk

FDA (Devices) recall action 95415

MEDLINE INDUSTRIES, LP - Northfield recalled 33 products on 2024-10-30

The FDA (Devices) publishes a recall like this one as 33 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 33 pages.

Products
33
Announced
2024-10-30
Critical
0
Units
100,579

Why these products were recalled

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

XXX

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.

1–25 of 33

  • HighFDA (Devices)··2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Sterility Compromise

    Medline is recalling specific medical procedure convenience kits because a packaging defect could allow non-sterile product to be used if the vendor seal is opened.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF D
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Procedure Kits Recalled for Non-Sterile Product Risk

    Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Centurion EP LAB INSTRUMENT KIT Recalled for Potential Sterility Compromise

    Medline Industries is recalling 90 units of Centurion EP LAB INSTRUMENT KIT convenience kits from lot 23LBK889. The kits may contain non-sterile product if the breather pouch vendor seal is opened or compromised.

    Product
    Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline medical procedure kits recalled due to potential non-sterile product risk

    Medline is recalling four types of medical procedure convenience kits that may contain non-sterile products if the pouch seal is opened. Approximately 197 units were distributed nationwide and internationally.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline dental pack may contain non-sterile product due to packaging defect

    Medline dental procedure kits may contain non-sterile product if the breather pouch seal is compromised. The recall affects 165 units distributed in the US, Canada, and Panama.

    Product
    Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Non-Sterile Product

    Medline brand medical procedure convenience kits are recalled because their packaging may allow product sterility to be compromised. The affected units were packaged in breather pouch lot 323080002.

    Product
    Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) L
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Medical Procedure Convenience Kits Recalled for Potential Sterility Issue

    Medline is recalling 312 medical procedure convenience kits due to potential sterility issues if the breather pouch seal is opened or damaged. The affected kits were distributed in the US, Canada, and Panama.

    Product
    Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline medical procedure kits recalled due to potential non-sterile packaging defect

    Medline brand medical procedure convenience kits packaged in breather pouch lot 323080002 may be non-sterile if the vendor seal is opened or compromised. Affected kits are distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PAC
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Medical Procedure Drape Packs Recalled Due to Non-Sterile Packaging Risk

    Medline is recalling 194 drape packs from breather pouch lot 323080002 that may be non-sterile if the seal is opened. The kits were distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk

    Medline is recalling certain medical procedure kits packaged in breather pouch lot 323080002 because seals may not prevent non-sterile product use. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ3272
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline EYE PACK Medical Kits Recalled for Potential Non-Sterile Packaging

    Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.

    Product
    Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Medical Procedure Kits Recalled Due to Non-Sterile Packaging Risk

    Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects units distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline catheter procedure kits recalled for potential sterility compromise

    Medline is recalling 8,830 medical procedure convenience kits with potential breather pouch seal failure that could allow non-sterile product use.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S;
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Medical Procedure Kits Recalled Due to Potential Non-Sterility Risk

    Medline is recalling approximately 1,048 medical procedure convenience kits that may become non-sterile if their protective pouch seal is compromised. The affected kits were packaged with breather pouches from lot 323080002.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF D
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Tubal Ligation Kits Recalled for Potential Sterility Compromise

    Medline is recalling certain tubal ligation procedure kits due to potential loss of sterility if the pouch seal becomes compromised during storage or handling.

    Product
    Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk

    Medline is recalling 88 convenience kits used in gynecological medical procedures due to potential non-sterility if the breather pouch seal is compromised. The affected lots are distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROSCOPY TRAY ACS, REF DYNJ68750
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline convenience kits recalled for potential use of non-sterile product

    Medline brand obstetric convenience kits packaged in breather pouch lot 323080002 may become non-sterile if the vendor seal is opened or unsealed.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, RE
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline chest tube insertion tray may contain non-sterile equipment due to breached seal

    Medline is recalling certain chest tube insertion trays due to potential sterility loss if the vendor seal is breached. Non-sterile equipment poses a serious risk during invasive medical procedures.

    Product
    Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Centurion OB Tray medical kit recalled due to potential non-sterility

    Medline's Centurion OB TRAY convenience kits with breather pouch lot 323080002 may be non-sterile if the pouch seal is opened or becomes unsealed, posing a risk in obstetric procedures.

    Product
    Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Ambulatory Mini Pack medical kits may be non-sterile if seal compromised

    Medline is recalling certain Ambulatory Mini Pack convenience kits from lot 23LBO804 because they may be non-sterile if the vendor seal on the breather pouch is opened or unsealed.

    Product
    Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline medical procedure kits recalled due to potential non-sterile packaging

    Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAV
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Medical Procedure Convenience Kits Recalled for Potential Non-Sterility Risk

    Medline is recalling certain medical procedure convenience kits due to a breather pouch seal defect. If the pouch seal is opened or compromised, the product may not be sterile and could pose a health risk during surgical use.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLO
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Dialysis Pack Recalled Due to Potential Non-Sterile Product Risk

    Medline is recalling 90 units of its dialysis convenience kit due to potential non-sterile product if the package seal is compromised. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-30

    Medline Central Catheter Insertion Kit Recalled for Potential Non-Sterile Packaging

    Medline CENTRAL CATHETER INSERTION KIT (Ref CVI680C) is being recalled because certain units may be non-sterile due to potential seal failures in packaging. The recall affects 1,180 units distributed in the US, Canada, and Panama.

    Product
    Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2024-10-30

    Medline Medical Procedure Convenience Kits Class II Recall

    Medline Industries recalls 22,327 units of medical procedure convenience kits distributed in the US, Canada, and Panama. The FDA Class II recall affects multiple kit variants and is currently ongoing.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST; 3) T&A CDS, REF CDS980427J; 4) EVD CDS, REF CDS984603; 5) CHEST DRAINAGE TRAY, REF CHT745; 6) TRAY FOL TEMP UM 14FR 10ML MF,
    Category
    Distribution
    0 states