Introducer sheath systems recalled over pouch labels showing the wrong size
Fortress Introducer Sheath Systems, 6F straight 45 cm, lot 800989, are recalled because units may carry a pouch label listing the reference number and UDI of the 4F version. 2,500 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a sheath labeled at the wrong French size could be selected in error, and no injuries are reported.
Plain-English summary
The Fortress Introducer Sheath System, 6F straight 45 cm, model number 386594, lot 800989, unique device identifier 04251244503703, is being recalled. The recall covers 2,500 units distributed across more than 13 states and internationally.
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. The FDA classified the action as Class II.
Hospitals holding this lot should quarantine it and follow the manufacturer's instructions for return or replacement, and should verify device size before use.
The recalled product
- Product
- Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:
- Manufacturer
- Contract Medical International GmbH
- Category
- Medical Device — Vascular Access
- Hazard
- mislabeling
- wrong-size
- introducer-sheath
- class-ii
Distribution
Distributed nationwide across the United States.
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