Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
Check against the official notice below — it lists the full affected range.
Medline Industries, LP is recalling 419 surgical convenience kits that contain a potentially contaminated component which was recalled by the manufacturer. The affected kits include CMH LITHO MINOR PACK-LF (SKU DYNJ54362F), EAST MAJOR LITHOTOMY (SKU DYNJ900957C), GYN LAPAROTOMY (SKU DYNJ906804B), and another kit (SKU DYNJ910195A). The kits were distributed nationwide across 18 states including Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, and Wisconsin.
Affected consumers can identify recalled kits by checking the SKU numbers and lot numbers listed in the recall. The specific lot numbers affected are 26EMF986, 25IBP434, 26BBA665, 25KBR602, 25JBH531, 25KBL876, and 25JBS218. The source document does not specify what actions consumers or healthcare facilities should take regarding these recalled kits.
Written by software from the official notice below. Not reviewed by a lawyer.
Kits contain a potentially contaminated component which were recalled by the manufacturer
Reason for recall: Kits contain a potentially contaminated component which were recalled by the manufacturer Distribution: US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI. Quantity: 419 kits Lot/code info: Medline Kit SKU DYNJ54362F, UDI/DI 10198459794292 (each) 40198459794293 (case), Lot Number 26EMF986; Medline Kit SKU DYNJ900957C, UDI/DI 10195327599461 (each) 40195327599462 (case), Lot Number 25IBP434; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 26BBA665; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25KBR602; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25JBH531; Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Number 25KBL876; Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Number 25JBS218.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.