Recall archive / FDA device enforcement
Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, ... — FDA record Z-2990-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2990-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 18, 2024
- Recall initiation date
- Apr 8, 2024
- Center classification date
- Sep 6, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.