FDAFDA · Food and drugs·Recall number Z-0567-2018
Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Published February 21, 2018 · Recall initiated: June 21, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B. Braun Medical, Inc.
- Distributor
- US Nationwide Distribution.
- Lot
- 0061482555. 0061515153. 0061518685. 0061520983. 0061520983. 0061528975. 0061547818. 0061486692. 0061518681. 0061523687. 0061529146. 0061539137. 0061546529.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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