FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: 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
- Recall number
- Z-2990-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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
- Status
- Open, Classified
- Initiated
- 2024-04-08
- Posted
- 2024-09-06
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
- Quantity
- not on file
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DTL
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28