Reprocessed Agilis Steerable Introducer: indicated for recall: Endotoxin
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve…
Why was Reprocessed Agilis Steerable Introducer: indicated for recalled?
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve…
- Recalling firm
- Sterilmed, Inc.
- Quantity
- 218 units
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, MN, and WA.
- Recall date
- October 17, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)