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MEDLINE DYNJ70141MBRecalls & reported problems

Medline Industries, Inc. · PICC KIT 4F SL PL MAX BARRIER · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653160362982), received between Feb 25, 2026 and Feb 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Flush” (1 report).

47 other recalls cover devices cleared under the same FDA submission (K213481); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Difficult to Flush1
  • Infusion or Flow Problem1
  • Obstruction of Flow1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 25, 2026Difficult to Flush; Obstruction of Flow

    ACCORDING TO THE FACILITY, ON (B)(6) 2026, STAFF WERE UNABLE TO FLUSH THE PICC LINE OR OBTAIN BLOOD RETURN. THE FACILITY STATED THAT THE PICC LINE HAD TO BE REMOVED AND THAT A CHEST X-RAY SHOWED THE PICC LINE WAS IN PLACE. THE CUSTOMER REPORTED THAT ANOTHER COMPANY PLACED A PICC LINE USING THEIR PRODUCT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24443223 ↗
  • MalfunctionFeb 25, 2026Infusion or Flow Problem

    ACCORDING TO THE FACILITY, SOMETIME IN THE PAST, STAFF WERE UNABLE TO FLUSH THE PICC LINE OR OBTAIN BLOOD RETURN. THE FACILITY STATED THAT THE PICC LINE HAD TO BE REMOVED, AND THAT A CHEST X-RAY SHOWED THE PICC LINE WAS IN PLACE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24441873 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K213481. One submission often covers many models, so check the product and lot details in each record.

  • Z-3267-2026 · Aug 10, 2026 · Open, Classified
    Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number:
  • Z-3229-2026 · Aug 10, 2026 · Open, Classified
    Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
  • Z-3209-2026 · Jul 31, 2026 · Open, Classified
    Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
  • Z-3137-2026 · Jul 23, 2026 · Open, Classified
    Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
  • Z-3070-2026 · Jul 20, 2026 · Open, Classified
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER
  • Z-3024-2026 · Jul 10, 2026 · Open, Classified
    Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ
  • Z-2995-2026 · Jul 8, 2026 · Open, Classified
    Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU
  • Z-3054-2026 · Jun 12, 2026 · Open, Classified
    Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Numb
  • Z-2736-2026 · Jun 10, 2026 · Open, Classified
    Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
  • Z-2764-2026 · Jun 8, 2026 · Open, Classified
    MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
  • Z-2749-2026 · Jun 5, 2026 · Open, Classified
    MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K;
  • Z-2747-2026 · Jun 5, 2026 · Open, Classified
    MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
  • Z-2748-2026 · Jun 5, 2026 · Open, Classified
    MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
  • Z-2611-2026 · May 28, 2026 · Open, Classified
    Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
  • Z-2697-2026 · May 28, 2026 · Open, Classified
    Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B;

…and 32 more.

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Sources and updates

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