Drug & Device Safety Atlas
Class II FDA device recall · Z-3061-2024

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: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYNJ0976092P ; 3) BURN PACK-LF, Pack Number DYNJ42829B ; 4) BURN PACK , Pack Number DYNJ54386C ; 5) LARGE BURN PACK , Pack Number DYNJ69770; 6) LARGE BURN PACK , Pack Number DYNJ69770A ; 7) SMALL BURN PACK , Pack Number DYNJ69797; 8) SMALL BURN PACK , Pack Number DYNJ69797A ; 9) BURN PACK-LF, Pack Number DYNJ82534; 10) BURN PACK-LF, Pack Number DYNJ82534H ; 11) BASIC BURN PACK , Pack Number DYNJ82729; 12) BURN PACK , Pack Number DYNJ83254; 13) BURN PACK , Pack Number DYNJ84744

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
DYNJ0781678S , Lot Number 19LMC634 ;  DYNJ0781678S , Lot Number 20AMD173 ;  DYNJ0781678S , Lot Number 20CMC665 ;  DYNJ0781678S , Lot Number 20EMB965 ;  DYNJ0781678S , Lot Number 20GMC952 ;  DYNJ0781678S , Lot Number 20JMD288 ;  DYNJ0781678S , Lot Number 21CMB052 ;  DYNJ0781678S , Lot Number 21CME303 ;  DYNJ0781678S , Lot Number 21GME666 ;  DYNJ0781678S , Lot Number 21IMD184 ;  DYNJ0781678S , Lot Number 21KMG512 ;  DYNJ0781678S , Lot Number 22AMF686 ;  DYNJ0781678S , Lot Number 22BMA737 ;  DYNJ0781678S , Lot Number 22DMI132 ;  DYNJ0781678S , Lot Number 22EMB432 ;  DYNJ0781678S , Lot Number 22EMI061 ;  DYNJ0781678S , Lot Number 22GMB212 ;  DYNJ0781678S , Lot Number 22IMC056 ;  DYNJ0781678S , Lot Number 22KMB510 ;  DYNJ0781678S , Lot Number 23AMD737 ;  DYNJ0781678S , Lot Number 23BMC741 ;  DYNJ0781678S , Lot Number 23CMG452 ;  DYNJ0781678S , Lot Number 23EMJ106 ;  DYNJ0781678S , Lot Number 23GMC393 ;  DYNJ0781678S , Lot Number 23HMB925 ;  DYNJ0781678S , Lot Number 23HMI837 ;  DYNJ0781678S , Lot Number 23JME009 ;  DYNJ0781678S , Lot Number 23LMG524 ;  DYNJ0976092P , Lot Number 22KBM419 ;  DYNJ0976092P , Lot Number 23ABI393 ;  DYNJ0976092P , Lot Number 23ABU953 ;  DYNJ0976092P , Lot Number 23CBO918 ;  DYNJ0976092P , Lot Number 23FBK157 ;  DYNJ0976092P , Lot Number 23FBO968 ;  DYNJ0976092P , Lot Number 23HBP114 ;  DYNJ0976092P , Lot Number 23JBJ268 ;  DYNJ0976092P , Lot Number 23JBX458 ;  DYNJ0976092P , Lot Number 23LBO309 ;  DYNJ42829B , Lot Number 21VBB243 ;  DYNJ42829B , Lot Number 21KBX160 ;  DYNJ42829B , Lot Number 21LBJ187 ;  DYNJ42829B , Lot Number 22CBG053 ;  DYNJ42829B , Lot Number 22DBM155 ;  DYNJ42829B , Lot Number 22EBF406 ;  DYNJ42829B , Lot Number 22EBQ033 ;  DYNJ42829B , Lot Number 22HBL593 ;  DYNJ42829B , Lot Number 22IBI084 ;  DYNJ42829B , Lot Number 22JBT931 ;  DYNJ54386C , Lot Number 21HMA145 ;  DYNJ54386C , Lot Number 21HMF539 ;  DYNJ54386C , Lot Number 22CMC496 ;  DYNJ54386C , Lot Number 22EMA072 ;  DYNJ54386C , Lot Number 22GMC085 ;  DYNJ54386C , Lot Number 22HMC997 ;  DYNJ54386C , Lot Number 23BMD997 ;  DYNJ54386C , Lot Number 23BME291 ;  DYNJ54386C , Lot Number 23BME299 ;  DYNJ54386C , Lot Number 23HMD808 ;  DYNJ54386C , Lot Number 23JME585 ;  DYNJ54386C , Lot Number 23KMJ519 ;  DYNJ54386C , Lot Number 24AMA687 ;  DYNJ69770, Lot Number 21JBZ854 ;  DYNJ69770, Lot Number 21KBG572 ;  DYNJ69770, Lot Number 22FBF083 ;  DYNJ69770, Lot Number 22GBS150 ;  DYNJ69770, Lot Number 22IBI498 ;  DYNJ69770, Lot Number 22IBI500 ;  DYNJ69770, Lot Number 23ABF148 ;  DYNJ69770A , Lot Number 23BBM922 ;  DYNJ69770A , Lot Number 23BBN136 ;  DYNJ69770A , Lot Number 23DBB253 ;  DYNJ69770A , Lot Number 23GBE013 ;  DYNJ69770A , Lot Number 23HBP947 ;  DYNJ69770A , Lot Number 23IBD392 ;  DYNJ69770A , Lot Number 23LBH034 ;  DYNJ69770A , Lot Number 24ABD199 ;  DYNJ69797, Lot Number 21VBB057 ;  DYNJ69797, Lot Number 22FBU011 ;  DYNJ69797, Lot Number 22IBL650 ;  DYNJ69797, Lot Number 22JBS235 ;  DYNJ69797, Lot Number 22LBN180 ;  DYNJ69797A , Lot Number 23ABR780 ;  DYNJ69797A , Lot Number 23CBC665 ;  DYNJ69797A , Lot Number 23DBA361 ;  DYNJ69797A , Lot Number 23DBP443 ;  DYNJ69797A , Lot Number 23FBD706 ;  DYNJ69797A , Lot Number 23GBH073 ;  DYNJ69797A , Lot Number 23IBI641 ;  DYNJ69797A , Lot Number 23JBM947 ;  DYNJ82534, Lot Number 22HBI219 ;  DYNJ82534, Lot Number 23ABI062 ;  DYNJ82534, Lot Number 23ABI245 ;  DYNJ82534, Lot Number 23ABT142 ;  DYNJ82534, Lot Number 23CBA657 ;  DYNJ82534, Lot Number 23FBA414 ;  DYNJ82534, Lot Number 23GBB353 ;  DYNJ82534, Lot Number 23HBN063 ;  DYNJ82534, Lot Number 23IBO398 ;  DYNJ82534, Lot Number 23KBP925 ;  DYNJ82534H , Lot Number 22HBI219 ;  DYNJ82534H , Lot Number 23ABI062 ;  DYNJ82534H , Lot Number 23ABI245 ;  DYNJ82534H , Lot Number 23ABT142 ;  DYNJ82534H , Lot Number 23CBA657 ;  DYNJ82534H , Lot Number 23FBA414 ;  DYNJ82534H , Lot Number 23GBB353 ;  DYNJ82534H , Lot Number 23HBN063 ;  DYNJ82534H , Lot Number 23IBO398 ;  DYNJ82534H , Lot Number 23KBP925 ;  DYNJ82729, Lot Number 22KMF062 ;  DYNJ82729, Lot Number 23CMF962 ;  DYNJ82729, Lot Number 23DMG875 ;  DYNJ82729, Lot Number 23EME128 ;  DYNJ82729, Lot Number 23FMB967 ;  DYNJ82729, Lot Number 23GMD583 ;  DYNJ82729, Lot Number 23IMG264 ;  DYNJ82729, Lot Number 23LMF995 ;  DYNJ82729, Lot Number 24AMC492 ;  DYNJ83254, Lot Number 22LBO275 ;  DYNJ83254, Lot Number 23CBM480 ;  DYNJ84744, Lot Number 23GMF409

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-3061-2024
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-3061-2024 · Source: openFDA enforcement.