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
- Company
- Sterilmed, Inc.
- Recall Initiated
- September 17, 2018
- Posted
- October 9, 2018
- Terminated
- August 4, 2020
- Recall Number
- Z-0090-2019
- Quantity
- 218 units
- Firm Location
- Plymouth, MN
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.
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
Root Cause
Material/Component Contamination
Action Taken
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.