MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTI

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: 00-401327AA, Lot Number 20AMA256 ; 00-401327AA, Lot Number 20AMC142 ; 00-401327AA, Lot Number 20BMB258 ; 00-401327AA, Lot Number 20DMB109 ; 00-401327AA, Lot Number 20GMB772 ; 00-401327AA, Lot Number 20HMC035 ; 00-401327AA, Lot Number 20JMA910 ; 00-401327AA, Lot Number 20JMB656 ; 00-401327AA, Lot Number 21CMA167 ; 00-401327AA, Lot Number 21EMB860 ; 00-401327AA, Lot Number 21FMC472 ; 00-401327AA, Lot Number 21GMF286 ; 00-401327AA, Lot Number 21HME693 ; 00-401327AA, Lot Number 21IMC842 ; 00-401327AA, Lot Number 21KMB315 ; 00-401594R , Lot Number 19LDA473 ; 00-401594R , Lot Number 20ADB972 ; 00-401594R , Lot Number 20CDC521 ; 00-401594R , Lot Number 20EDB836 ; 00-401594R , Lot Number 20HDA321 ; 00-401594R , Lot Number 21CDB556 ; 00-401594R , Lot Number 21EDA344 ; 00-401808S , Lot Number 21GBR684 ; 00-401808S , Lot Number 21IBB505 ; 00-401808S , Lot Number 21JBD593 ; 00-401808S , Lot Number 21JBD594 ; 00-401808S , Lot Number 21JBD596 ; 00-401808S , Lot Number 22ABS576 ; 00-401808S , Lot Number 19ABL630 ; 00-401808S , Lot Number 22NBA002 ; 00-401808S , Lot Number 19BBJ217 ; 00-401808S , Lot Number 22OBB643 ; 00-401808S , Lot Number 19DBK655 ; 00-401808S , Lot Number 22FBO951 ; 00-401808S , Lot Number 19FBI621 ; 00-401808S , Lot Number 19FBV633 ; 00-401808S , Lot Number 22HBR194 ; 00-401808S , Lot Number 22IBG899 ; 00-401808S , Lot Number 19HBL271 ; 00-401808S , Lot Number 22JBH625 ; 00-401808S , Lot Number 19IBG849 ; 00-401808S , Lot Number 22KBP137 ; 00-401808S , Lot Number 19IBZ7

Source

Official record: FDA (Device enforcement) ↗

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