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-RENAI

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Lot/code info: 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 ; CDS98

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.