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) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132701; 3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ; 4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ; 5) KIT ANGIO CSTM-SETON, Pack Number 143267; 6) SYR- VA HOSPITAL, Pack Number 144684; 7) BYPASS ENCOMPASS CDS, Pack Number CDS985003A; 8) CSTM MANIFOLD KIT , Pack Number SAMPC0547; 9) CSTM MANIFOLD KIT - FRYE, Pack Number VASC1074 ; 10) CSTM MANIFOLD KIT , Pack Number VASC1130
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
129736 , Lot Number 20DKA054 ; 132701, Lot Number 24ADB481; 132701, Lot Number 24ADA120; 132701, Lot Number 23GDC081; 132701, Lot Number 23DDC268; 132701, Lot Number 23CDC677; 132701, Lot Number 22LDA569; 132701, Lot Number 22IDC180; 132701, Lot Number 22IDA238; 132701, Lot Number 22DDB501; 132701, Lot Number 22DDA530; 132701, Lot Number 22ADB638; 132701, Lot Number 21KDB209; 132701, Lot Number 21KDA233; 132701, Lot Number 21JDA611; 132701, Lot Number 21FDC090; 132701, Lot Number 21EDB524; 132701, Lot Number 21CDB488; 132701, Lot Number 20LDB085; 132701, Lot Number 20KDA727; 132701, Lot Number 20FDC203; 132701, Lot Number 20BDB590; 132701, Lot Number 20BDA433; 134085 , Lot Number 22BBZ656Z; 142643 , Lot Number 22NBF339Z; 143267, Lot Number 22GMA268; 144684, Lot Number 24AMB389; 144684, Lot Number 23LMG949; 144684, Lot Number 23KMJ307; 144684, Lot Number 23HMI452; 144684, Lot Number 23GMB839; 144684, Lot Number 23FMI280; 144684, Lot Number 23DMH268; 144684, Lot Number 23CMH563; 144684, Lot Number 23BMF752; 144684, Lot Number 22LMA051; 144684, Lot Number 22IMA306; CDS985003A, Lot Number 24CMC421; CDS985003A, Lot Number 24CMC421; CDS985003A , Lot Number 21GBM644 ; CDS985003A , Lot Number 19BBN133 ; CDS985003A , Lot Number 19CBQ620 ; CDS985003A , Lot Number 19EBW590 ; CDS985003A , Lot Number 19GBB647 ; CDS985003A , Lot Number 19LBU108 ; CDS985003A , Lot Number 20ABT969 ; CDS985003A , Lot Number 20ABW952 ; CDS985003A , Lot Number 20DBD342 ; CDS985003A , Lot Number 20EBS254 ; CDS985003A , Lot Number 20GBJ904 ; CDS985003A , Lot Number 20IBG340 ; CDS985003A , Lot Number 20JBP424 ; CDS985003A , Lot Number 20KBU982 ; CDS985003A , Lot Number 21CBW933 ; CDS985003A , Lot Number 21EBE602 ; CDS985003A , Lot Number 22CMA036 ; CDS985003A , Lot Number 22DMI553 ; CDS985003A , Lot Number 23DMH255 ; CDS985003A , Lot Number 23DMH760 ; CDS985003A , Lot Number 23FMF204 ; CDS985003A , Lot Number 23GMB004 ; CDS985003A , Lot Number 23GMI569 ; CDS985003A , Lot Number 23JMJ652 ; CDS985003A , Lot Number 24AMB671 ; SAMPC0547, Lot Number 19BDB826 ; VASC1074 , Lot Number 22BBR869 ; VASC1130 , Lot Number 20LME799
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-2990-2024
- 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-2990-2024 · Source: openFDA enforcement.