Recall Z-0090-2019— Sterilmed, Inc.
Class II · Terminated
Class II FDA medical device recall by Sterilmed, Inc., initiated 2018-09-17, terminated 2020-08-04. It names one FDA 510(k) clearance: K152090. 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: Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing..
- Recalling firm
- Sterilmed, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-17
- Terminated
- 2020-08-04
- Firm location
- Plymouth, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.