Recall Z-0090-2019 ยท PNH
Sterilmed, Inc.
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
| Date | Oct 9, 2018 (initiated Sep 17, 2018) |
| Status | Terminated |
| Reason | Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing. |
| Root cause | Material/Component Contamination |
| Action | Sterilmed notified customers on about 09/17/2018, via URGENT MEDICAL DEVICE RECALL letter sent via UPS next day. Instructions included examine inventory for affected devices, remove and return affected devices to Stericycle (3rd party processor), provide recall information to appropriate personnel at the facility, and complete and return the Business Reply Form to Stericycle. For questions, contact Sterilmed's Customer Care Team at (888) 541-0078, Monday through Friday from 7:00 AM to 5:00 PM CST. |
| Quantity | 218 units |
| Distribution | U.S. Nationwide distribution in the states of CA, CO, MN, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152090 | Reprocessed Steerable Introducer Sterilmed, Inc., Mar 23, 2016 |