Z-0090-2019 Class II Terminated
FDA device recall Z-0090-2019 was initiated by Sterilmed, Inc. on September 17, 2018 and is designated Class II. Reason for recall: Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing. The recall status is terminated (terminated August 4, 2020). Affected quantity: 218 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2018
- Initiation Date
- September 17, 2018
- Termination Date
- August 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 218 units
Product Description
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.
Distribution Pattern
U.S. Nationwide distribution in the states of CA, CO, MN, and WA.
Code Information
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