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
Reported: October 17, 2018 Initiated: September 17, 2018 #Z-0090-2019
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.
Details
- Recalling Firm
- Sterilmed, Inc.
- Units Affected
- 218 units
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, MN, and WA.
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sterilmed, Inc.. Units affected: 218 units.
Why was this product recalled? ▼
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 17, 2018. Severity: Moderate. Recall number: Z-0090-2019.
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