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

MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack

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: DYNJ17400B, Lot Number 23ABV075; DYNJ17400B, Lot Number 23ABV141; DYNJ17400B, Lot Number 22KBA557; DYNJ17400B, Lot Number 22GBJ307; DYNJ17400B, Lot Number 22DBU457; DYNJ32049A , Lot Number 19AKB211 ; DYNJ32049A , Lot Number 19CKA247 ; DYNJ44987G , Lot Number 21FBJ607 ; DYNJ44987G , Lot Number 21IBE237 ; DYNJ44987G , Lot Number 21KBA883 ; DYNJ44987G , Lot Number 21LBO984 ; DYNJ44987G , Lot Number 22CBN087 ; DYNJ44987G , Lot Number 20BBQ959 ; DYNJ44987G , Lot Number 20FBI170 ; DYNJ44987G , Lot Number 20JBL731 ; DYNJ44987G , Lot Number 21ABF141 ; DYNJ44987G , Lot Number 21CBF976 ; DYNJ44987G , Lot Number 21DBW445 ; DYNJ66288, Lot Number 20DBE878

Source

Official record: FDA (Device enforcement)

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

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