Recall Z-0571-2018— B. Braun Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2017-06-21, terminated 2018-04-03. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- B. Braun Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-21
- Terminated
- 2018-04-03
- Firm location
- Allentown, PA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.