Sterilmed, Inc. Recall: Reprocessed Agilis Steerable Introducer: indicated for introducing
Sterilmed, Inc. Recall: Reprocessed Agilis Steerable Introducer: indicated for introducing is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Sterilmed, Inc.; Product: Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) s
| Recalling firm | Sterilmed, Inc. |
|---|---|
| Product | 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 cm length), Product Code STJ408324 |
| Reason for recall | Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | U.S. Nationwide distribution in the states of CA, CO, MN, and WA. |
| Recall initiated | 20180917 |
| Recall number | Z-0090-2019 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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