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
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, ClassifiedMedline 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, ClassifiedMedline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
- Z-3209-2026 · Jul 31, 2026 · Open, ClassifiedConvenience kits MYRINGOTOMY PACK-LF DYNJ59097A
- Z-3137-2026 · Jul 23, 2026 · Open, ClassifiedMedline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
- Z-3070-2026 · Jul 20, 2026 · Open, ClassifiedMedline 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, ClassifiedMedline 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, ClassifiedMedline 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, ClassifiedMedline 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, ClassifiedMedline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
- Z-2764-2026 · Jun 8, 2026 · Open, ClassifiedMEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
- Z-2749-2026 · Jun 5, 2026 · Open, ClassifiedMEDLINE 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, ClassifiedMEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
- Z-2748-2026 · Jun 5, 2026 · Open, ClassifiedMEDLINE 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, ClassifiedMedline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
- Z-2697-2026 · May 28, 2026 · Open, ClassifiedMedline 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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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