Sterilmed Recalls Reprocessed Agilis Steerable Introducers Due to Endotoxin Concerns
Sterilmed, Inc. is recalling 218 reprocessed Agilis Steerable Introducers because they may not meet endotoxin requirements. The devices were distributed in California, Colorado, Minnesota, and Washington.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential biological hazard (endotoxin) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Sterilmed, Inc. is recalling 218 units of reprocessed Agilis Steerable Introducers. These medical devices are indicated for introducing various cardiovascular catheters into the heart. The recall involves specific product codes STJ408309, STJ408310, and STJ408324 with expiration dates prior to June 8, 2019.
The recall was initiated because the reprocessed devices may not meet endotoxin requirements per product specification for biological residues, as determined by LAL testing. Endotoxins are biological residues that can cause adverse reactions if introduced into the body.
The affected devices were distributed nationwide in the states of California, Colorado, Minnesota, and Washington. Healthcare providers and facilities that have these devices should stop using them and contact Sterilmed, Inc. for further instructions.
The recalled product
- 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) la
- Manufacturer
- Sterilmed, Inc.
- Category
- Medical Device — Cardiovascular
- Affected units
- 218
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- GTIN 10888551044912 (b) Product Code STJ408310
- GTIN 10888551044929 (c) Product Code STJ408324
- GTIN 10888551044950
Distribution
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