Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Reported: February 21, 2018 Initiated: June 21, 2017 #Z-0573-2018
Product Description
Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. 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.
Details
- Recalling Firm
- B. Braun Medical, Inc.
- Units Affected
- 2660 units
- Distribution
- US Nationwide Distribution.
- Location
- Allentown, PA
Frequently Asked Questions
What product was recalled? ▼
Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.. Recalled by B. Braun Medical, Inc.. Units affected: 2660 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0573-2018.
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