Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; 6) HEAD & NECK PACK
Check against the official notice below — it lists the full affected range.
Medline Industries is recalling 2,262 medical convenience kits distributed nationwide across 17 states due to potential out-of-specification levels of endotoxin found in Pilling Wecksorb Neurosponges and Neurosponge Strips contained in the kits. The affected products are labeled as Sinus Pack-LF (SKU DYNJ0966146F), ENT Pack (SKUs DYNJ40154D and DYNJ40154F), and additional kit models, with specific lot numbers identified for each product.
The recall affects kits distributed in Arizona, California, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, New York, Ohio, Texas, Wisconsin, and Wyoming. The source document does not specify a remedy for consumers who have these kits.
Written by software from the official notice below. Not reviewed by a lawyer.
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
Reason for recall: Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges. Distribution: US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY. Quantity: 2262 kits Lot/code info: Medline Kit SKU DYNJ0966146F, UDI/DI 10193489916379 (each) 40193489916370 (case), Lot Number 23HBC070; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 24CBA416; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23CBS214; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23FBC803; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23GBU042; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23IBO417; Medline Kit SKU DYNJ40154F, UDI/DI 10195327679293 (each) 40195327679294 (case), Lot Number 24EBH594; Medline Kit SKU DYNJ40154F, UDI/DI 10195327679293 (each) 40195327679294 (case), Lot Number 24FBQ494; Medline Kit SKU DYNJ40154F, UDI/DI 10195327679293 (each) 40195327679294 (case), Lot Number 24JBK316; Medline Kit SKU DYNJ44480D, UDI/DI 10198459241727 (each) 40198459241728 (case), Lot Number 25CDA135; Medline Kit SKU DYNJ58928A, UDI/DI 10193489763973 (each) 40193489763974 (case), Lot Number 23HBK833; Medline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 24FBQ476; Medline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 23EBI941; Medline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 23HBX888; Medline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Numb
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.