FDAFDA · Food and drugs·Recall number Z-0090-2019
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
Published October 17, 2018 · Recall initiated: September 17, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sterilmed, Inc.
- Distributor
- U.S. Nationwide distribution in the states of CA, CO, MN, and WA.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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