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FDA (Device enforcement)Recalled 2024-04-08class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049

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: C040100, Lot Number 19BDB794 ; C040100, Lot Number 19BDB938 ; C040100, Lot Number 19CDD009 ; C040100, Lot Number 19EDC262 ; C040100, Lot Number 19EDC533 ; C040100, Lot Number 19JDA569 ; C040100, Lot Number 19JDA836 ; C040100, Lot Number 19JDC293 ; C040100, Lot Number 19LDB582 ; C040100, Lot Number 20BDA227 ; C040100, Lot Number 20BDA828 ; C040100, Lot Number 20BDC639 ; C040100, Lot Number 20DDA503 ; C040100, Lot Number 20DDA627 ; C040100, Lot Number 20HDC033 ; C040100, Lot Number 21HDA277 ; C040100, Lot Number 22EDB968 ; C040100, Lot Number 22HDB951 ; CDS760049AD, Lot Number 21IBC904 ; CDS760049AD, Lot Number 21IBM329 ; CDS760049AD, Lot Number 21LBS989 ; CDS760049AD, Lot Number 22CBW119 ; CDS760049AD, Lot Number 22OBL416 ; CDS760049AD, Lot Number 22OBL970 ; CDS760049AD, Lot Number 22GBD274 ; CDS760049AD, Lot Number 22IBF092 ; CDS760049AD, Lot Number 22JBF094 ; CDS760049AD, Lot Number 22KBF472 ; CDS760049AD, Lot Number 22KBI850 ; CDS760049AD, Lot Number 23ABF834 ; CDS760049AD, Lot Number 23BBK772 ; CDS760049AD, Lot Number 23CBT560 ; CDS760049AD, Lot Number 23EBO959 ; CDS760049AD, Lot Number 23GBP399 ; CDS760049AD, Lot Number 23GBT911 ; CDS760049AD, Lot Number 23IBQ689 ; CDS760049AD, Lot Number 23JBI109 ; CDS760049AD, Lot Number 23KBD213 ; CDS760049AF, Lot Number 23LBV054 ; CDS760049AF, Lot Number 24ABR231 ; CDS760056G , Lot Number 22BBZ815 ; CDS760056G , Lot Number 22OBM631 ; CDS760056G , Lot Number 22JBI460 ; CDS760056G , Lot Number 23ABP479 ; CDS760056G , Lot Number 23FBG175

Source

Official record: FDA (Device enforcement)

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

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