Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
Check against the official notice below — it lists the full affected range.
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Reason for recall: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. Distribution: Domestic: IL, NC, VA, WY; Quantity: 240 kits Lot/code info: Model/Item Number (Kit): PM415; UDI-DI: 10809160322154; Kit Lots: 1652485, 1656642, 1667835, 1676219, 1682251, 1691940; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.