FDA-Device2018-02-21Class II
Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical, Inc.
Hazard
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
Sold states
US Nationwide Distribution.
Affected count
6720 units
Manufactured in
901 Marcon Blvd, Allentown, PA, United States
Products
Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0571-2018Don't want to check this manually?
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