Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71
Check against the official notice below — it lists the full affected range.
Sterilmed, Inc. is recalling reprocessed Agilis Steerable Introducers, which are devices used to introduce cardiovascular catheters into the heart. The devices may not meet endotoxin requirements for biological residues as specified in the product specifications. The recall affects 218 units distributed nationwide in California, Colorado, Minnesota, and Washington, and involves all lots with expiration dates prior to June 8, 2019, across three product codes.
The source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Reason for recall: Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing. Distribution: U.S. Nationwide distribution in the states of CA, CO, MN, and WA. Quantity: 218 units Lot/code info: All lots with expiration dates prior to 2019-06-08 of the following: (a) Product Code STJ408309, GTIN 10888551044912 (b) Product Code STJ408310, GTIN 10888551044929 (c) Product Code STJ408324, GTIN 10888551044950
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.