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

MEDLINE INDUSTRIES, LP - Northfield: Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH LAB-LF , 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: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON. Quantity: 1,679,067 units in total Lot/code info: CMPJ08068F , Lot Number 24ABN950 ; CMPJ11455B , Lot Number 23IBD357 ; DYNJ26938J , Lot Number 22FBD709 ; DYNJ26938J , Lot Number 22GBH459 ; DYNJ26938J , Lot Number 22HBR225 ; DYNJ26938J , Lot Number 22IBJ562 ; DYNJ26938J , Lot Number 22JBP469 ; DYNJ26938J , Lot Number 23ABM365 ; DYNJ26938J , Lot Number 23CBM109 ; DYNJ26938J , Lot Number 23DBN340 ; DYNJ26938J , Lot Number 23GBH016 ; DYNJ26938J , Lot Number 23IBS867 ; DYNJ53018, Lot Number 21IBX266 ; DYNJ53018, Lot Number 22GBN555 ; DYNJ53018, Lot Number 23ABN207 ; DYNJ57729C , Lot Number 23HBK882 ; DYNJ57729C , Lot Number 24ABO025 ; DYNJ66856, Lot Number 21KBH003 ; DYNJ66856A , Lot Number 22DBD158 ; DYNJ66856A , Lot Number 22FBY433 ; DYNJ66856A , Lot Number 22GBK576 ; DYNJ66856A , Lot Number 22HBQ139 ; DYNJ66856A , Lot Number 22IBO303 ; DYNJ66856A , Lot Number 22JBO861 ; DYNJ66856A , Lot Number 22JBQ914 ; DYNJ66856A , Lot Number 23ABT952 ; DYNJ66856A , Lot Number 23CBF157 ; DYNJ66856A , Lot Number 23EBE461 ; DYNJ66856A , Lot Number 23EBI477 ; DYNJ66856A , Lot Number 23HBD973 ; DYNJ81061A , Lot Number 23HBN396 ; DYNJ84617, Lot Number 23FBR368 ; DYNJ49920L , Lot Number 23KMB066 ; UVT1190A , Lot Number 23BLA187 ; UVT1190A , Lot Number 23DLA246 ; UVT1190A , Lot Number 23KLA117 ; UVT1190A , Lot Number 23LLA329

Source

Official record: FDA (Device enforcement)

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

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