Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
Reported: August 8, 2018 Initiated: May 2, 2018 #Z-2562-2018
Product Description
Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
Reason for Recall
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
Details
- Recalling Firm
- Galt Medical Corporation
- Units Affected
- 10950
- Distribution
- U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea
- Location
- Garland, TX
Frequently Asked Questions
What product was recalled? ▼
Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055. Recalled by Galt Medical Corporation. Units affected: 10950.
Why was this product recalled? ▼
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 8, 2018. Severity: Moderate. Recall number: Z-2562-2018.
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