Class II FDA device recall · Z-3027-2024

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 5) PORT TRAY , Pack Number DT19245; 6) BIOPSY KIT, Pack Number DYNDA1466A; 7) BIOPSY KIT, Pack Number DYNDA1466A; 8) CATH REMOVAL, Pack Number DYNDA1733B; 9) CATH REMOVAL, Pack Number DYNDA1814; 10) CATH REMOVAL, Pack Number DYNDA1814; 11) CATH REMOVAL, Pack Number DYNDA1814; 12) CATH REMOVAL, Pack Number DYNDA1814; 13) CATH REMOVAL, Pack Number DYNDA1814; 14) CATH REMOVAL, Pack Number DYNDA1814; 15) CATH REMOVAL, Pack Number DYNDA1814; 16) CATH REMOVAL, Pack Number DYNDA1814; 17) SHUNT TRAY, Pack Number DYNDA2725; 18) PORT ACCESS KIT, Pack Number DYNDC2945; 19) PORT ACCESS KIT, Pack Number DYNDC2945; 20) PORT ACCESS KIT, Pack Number DYNDC2945; 21) PORT ACCESS KIT, Pack Number DYNDC2945; 22) PORT ACCESS KIT, Pack Number DYNDC2945; 23) PORT ACCESS KIT, Pack Number DYNDC2945; 24) PORT ACCESS KIT, Pack Number DYNDC2945; 25) PORT ACCESS KIT, Pack Number DYNDC2945; 26) PORT ACCESS KIT, Pack Number DYNDC2945; 27) PORT ACCESS KIT, Pack Number DYNDC2945; 28) ARTHROGRAM TRAY, Pack Number DYNDH1113; 29) BIOPSY TRAY, Pack Number DYNDH1137C; 30) BIOPSY PACK, Pack Number DYNDH1248; 31) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 32) MYELOGRAM TRAY, Pack Number DYNDH1531; 33) BIOPSY PACK, Pack Number DYNDL1462B; 34) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B; 35) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B; 36) PORT ACCESS TRAY, Pack Number EBSI1241; 37) PORT ACCESS TRAY, Pack Number EBSI1241; 38) PORT ACCESS TRAY, Pack Number EBSI1241; 39) PORT ACCESS TRAY, Pack Number EBSI1241; 40) PORT ACCESS TRAY, Pack Number EBSI1241; 41) PORT ACCESS TRAY, Pack Number EBSI1241; 42) PORT ACCESS TRAY, Pack Number EBSI1241; 43) PORT ACCESS TRAY, Pack Number EBSI1241; 44) PORT ACCESS TRAY, Pack Number EBSI1241; 45) PORT ACCESS TRAY, Pack Number EBSI1241; 46) PORT ACCESS TRAY, Pack Number EBSI1241; 47) PORT ACCESS TRAY, Pack Number EBSI1241; 48) PORT ACCESS TRAY, Pack Number EBSI1241; 49) PORT ACCESS TRAY, Pack Number EBSI1241; 50) PORT ACCESS TRAY, Pack Number EBSI1241; 51) PORT ACCESS TRAY, Pack Number EBSI1241; 52) PORT ACCESS TRAY, Pack Number EBSI1241; 53) PORT ACCESS TRAY, Pack Number EBSI1241; 54) DIALYSIS CHANGE KIT, Pack Number EBSI1453; 55) DIALYSIS CHANGE KIT, Pack Number EBSI1453; 56) DIALYSIS CHANGE KIT, Pack Number EBSI1453A; 57) DIALYSIS CHANGE KIT, Pack Number EBSI1453A; 58) OB DELIVERY TRAY, Pack Number MNS10875A; 59) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 60) OB DELIVERY SET, Pack Number MNS3355; 61) LUMBAR TRAY, Pack Number SPEC0177; 62) 22G FACET TRAY, Pack Number SPEC0265A; 63) FINE LACERATION KIT, Pack Number SUT19360; 64) LACERATION TRAY, Pack Number SUT20955; 65) LACERATION TRAY, Pack Number SUT3780; 66) LACERATION TRAY, Pack Number SUT3780; 67) SUTURING SET, Pack Number SUT4020

Why it was recalled

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

ART245C, Lot Number 2023083090;  CHT1900, Lot Number 2020092590;  CHT560, Lot Number 2020110590;  CHT705, Lot Number 2023011790;  DT19245        , Lot Number 21JBN311 ;  DYNDA1466A, Lot Number 2021111090;  DYNDA1466A, Lot Number 2023091890;  DYNDA1733B, Lot Number 2019021950;  DYNDA1814, Lot Number 2018103050;  DYNDA1814, Lot Number 2018121450;  DYNDA1814, Lot Number 2019010950;  DYNDA1814, Lot Number 2019021950;  DYNDA1814, Lot Number 2019041850;  DYNDA1814, Lot Number 2019112250;  DYNDA1814, Lot Number 2020031350;  DYNDA1814, Lot Number 2020100801;  DYNDA2725, Lot Number 2023011790;  DYNDC2945, Lot Number 2020071090;  DYNDC2945, Lot Number 2020090990;  DYNDC2945, Lot Number 2020110590;  DYNDC2945, Lot Number 2020122890;  DYNDC2945, Lot Number 2021081890;  DYNDC2945, Lot Number 2021120890;  DYNDC2945, Lot Number 2022121290;  DYNDC2945, Lot Number 2023011090;  DYNDC2945, Lot Number 2023080790;  DYNDC2945, Lot Number 2023091890;  DYNDH1113, Lot Number 2020031350;  DYNDH1137C, Lot Number 2021011890;  DYNDH1248, Lot Number 2019021950;  DYNDH1359, Lot Number 2023080790;  DYNDH1531, Lot Number 2022020990;  DYNDL1462B, Lot Number 2019010950;  EBSI1039B, Lot Number 2023083090;  EBSI1039B, Lot Number 2023110390;  EBSI1241, Lot Number 2019120590;  EBSI1241, Lot Number 2020040390;  EBSI1241, Lot Number 2020061990;  EBSI1241, Lot Number 2020092590;  EBSI1241, Lot Number 2020111390;  EBSI1241, Lot Number 2021011890;  EBSI1241, Lot Number 2021041290;  EBSI1241, Lot Number 2021091590;  EBSI1241, Lot Number 2021111090;  EBSI1241, Lot Number 2021120690;  EBSI1241, Lot Number 2022020990;  EBSI1241, Lot Number 2022042290;  EBSI1241, Lot Number 2022072690;  EBSI1241, Lot Number 2022082990;  EBSI1241, Lot Number 2022101390;  EBSI1241, Lot Number 2023011790;  EBSI1241, Lot Number 2023090690;  EBSI1241, Lot Number 2023110390;  EBSI1453, Lot Number 2022022180;  EBSI1453, Lot Number 2022032880;  EBSI1453A, Lot Number 2022093090;  EBSI1453A, Lot Number 2023083090;  MNS10875A, Lot Number 2023011790;  MNS12150, Lot Number 2022121290;  MNS3355, Lot Number 2020071090;  SPEC0177, Lot Number 2019120590;  SPEC0265A, Lot Number 2019120590;  SUT19360, Lot Number 2022042290;  SUT20955, Lot Number 2020092590;  SUT3780, Lot Number 2020061990;  SUT3780, Lot Number 2020111390;  SUT4020, Lot Number 2023091890

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-3027-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Origin: Northfield, IL
Recall initiated: 2024-04-08

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-3027-2024 · Source: openFDA enforcement.