Anterior Hip Pack - Surgical Kit
Check against the official notice below — it lists the full affected range.
Stradis Medical, LLC dba Stradis Healthcare is recalling Anterior Hip Pack Surgical Kits because the outer bag may be perforated or torn, which could compromise the sterility of the kit. The recall affects 100 units distributed nationwide in Indiana, Texas, and Pennsylvania. The affected kits are identified by SKU/Part Number 570-2677 and UDI H65257026770, with the following lot numbers: 20170461910, 20163461674, 20170462303, 20219463245, 20238464203, 20268464581, 21082472172, 21110472562, 21138473542, 21167474498, 21287478853, and 21349479943.
The source record does not specify what actions affected consumers or healthcare facilities should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Reason for recall: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of IN, TX, and PA. Quantity: 100 units Lot/code info: SKU/Part Number 570-2677; UDI H65257026770 Lot Numbers: 20170461910, 20163461674, 20170462303, 20219463245, 20238464203, 20268464581, 21082472172, 21110472562, 21138473542, 21167474498, 21287478853, 21167474498, 21349479943
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.