Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Reason for recall: Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed. Distribution: U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI. Quantity: 22 units Lot/code info: Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047
00816777026118
Official record: FDA (Device enforcement) ↗
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