Potential for the outer stainless-steel tube to break or detach.
Reason for recall: Potential for the outer stainless-steel tube to break or detach. Distribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA. Quantity: 3,010 units Lot/code info: Model/Catalog Number: RX14-5011. GTINs: Pouch - 00841019109922, Inner Pack - 10841019109929, Case - 20841019109926. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.
00841019109922, 10841019109929, 20841019109926
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.