MEDLINE INDUSTRIES, LP - Northfield: Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4)

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 Lot/code info: CDS980203S, Lot Numbers:23DBT154; CDS980203S, Lot Numbers:23HBT797; CDS980203S, Lot Numbers:23JBM122; CDS980203S, Lot Numbers:23LBC884; CDS980203S, Lot Numbers:21CBW683; CDS982016T, Lot Numbers:22GBM951; CDS982016T, Lot Numbers:22GBO165; CDS982016T, Lot Numbers:22HBS644; CMPJ01846O, Lot Numbers:21LBQ988; CMPJ01846O, Lot Numbers:22FBV101; CMPJ05884J, Lot Numbers:21KBO037; CMPJ05884J, Lot Numbers:21KBU691; CMPJ05884J, Lot Numbers:21LBH778; CMPJ05884J, Lot Numbers:22IBG052; CMPJ05884J, Lot Numbers:22JBN865; CMPJ09860D, Lot Numbers:23KMB793; CMPJ09914C, Lot Numbers:23IDA209; CMPJ13389A, Lot Numbers:23CBL552; CMPJ13389B, Lot Numbers:23IBC818; CMPJ13389C, Lot Numbers:23KBU012; CMPJ13389C, Lot Numbers:23LBF106; CMPJ13389C, Lot Numbers:24ABD504; CMPJ13389C, Lot Numbers:24ABY610; CMPJ13389C, Lot Numbers:24BBV889; CMPJ13509, Lot Numbers:23IBF142; CMPJ21114O, Lot Numbers:23BBQ474; CMPJ21114O, Lot Numbers:23HBG033; CMPJ21114O, Lot Numbers:23IBV766; CMPJ21114O, Lot Numbers:23JBM292; CMPJ21114O, Lot Numbers:23KBK531; CMPJ21114O, Lot Numbers:21BBJ985; DYNJ0425965G, Lot Numbers:23GMH984; DYNJ0774664K, Lot Numbers:23HBP871; DYNJ40560B, Lot Numbers:23HBF219; DYNJ40560BH , Lot Numbers:23HBF219; DYNJ44134C, Lot Numbers:22JBQ075; DYNJ44134D, Lot Numbers:23BBK410; DYNJ44134D, Lot Numbers:23CBS145; DYNJ44134F, Lot Numbers:23EBC602; DYNJ44134F, Lot Numbers:23GBV482; DYNJ44134F, Lot Numbers:23JBP398; DYNJ44134F, Lot Numbers:23KBN024; DYNJ44134F, Lot Numbers:24ABC027; DYNJ45577A, Lot Numbers:21KBL221;

Source

Official record: FDA (Device enforcement) ↗

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