Perifix Continuous Epidural Anesthesia Tray. Product recall: Foreign Material
Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional…
Why was Perifix Continuous Epidural Anesthesia Tray. Product recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
0061482555. 0061515153. 0061518685. 0061520983. 0061520983. 0061528975. 0061547818. 0061486692. 0061518681. 0061523687. 0061529146. 0061539137. 0061546529.
- Product
- Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional…
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 8630 units
- Distribution
- US Nationwide Distribution.
- Recall date
- February 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)