Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Reason for recall: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Quantity: 7 units Lot/code info: UDI/DI 08436046002166, Serial Numbers: G79192, G79195, G79212, G78205, G80256, G79692, G80053.
08436046002166
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.