Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: For
Sold At: Contract Medical International GmbH(Worldwide - US Nationwide distribution in the states of CA, CT, FL, GA, KY, MA, MI, MO, NJ, NY, OR, RI, SC, TN, TX and the countries of Switzerland, Hungary, Italy, France, Denmark, Austria, Australia, Belgium, Poland, Germany, Bulgaria, Kazakhstan, Finland, Ireland, South Korea, Taiwan, Israel, Spain, Vietnam, Malaysia, Czechia, Thailand, Libya, Great Britain, Chile, Slovakia, Slovenia, Croatia, Sweden, Argentina.)
Recall #: FDA-DEVICE-Z-2532-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Lot Code: Model Number: 386594 Lot Number: 800989 Unique Device Identifier: 04251244503703 Expiration Date: 31 OCT 2027.
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Summary
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Contract Medical International GmbH for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.