Reported Oct 17, 2018 · Terminated
Reprocessed Agilis Steerable Introducer
Sterilmed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sterilmed, Inc. · 5010 Cheshire Pkwy N Ste 2 · Plymouth, MN · 55446-4101
Is this the product you have?
Reprocessed Agilis Steerable Introducer
3 of 3 products
| Model / number | Product as published |
|---|---|
STJ408309 | indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length) |
STJ408310 | (b) medium curl (22.4 mm curve type/71 cm length) |
STJ408324 | (c) large curl (50 mm curve type/71 cm length) |
- Lot codes and dates
- 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
- Amount recalled
- 218 units
Where it was sold
Why it was recalled
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
This product could cause temporary or reversible health problems — stop using it.
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