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U.S. Department of Health and Human Services

Class 2 Device Recall Customer Epidural Anesthesia Tray

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  Class 2 Device Recall Customer Epidural Anesthesia Tray see related information
Date Initiated by Firm June 21, 2017
Create Date February 09, 2018
Recall Status1 Terminated 3 on April 03, 2018
Recall Number Z-0574-2018
Recall Event ID 78878
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product Customer Epidural Anesthesia Tray. Product Catalog Number: 555234.

Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Code Information 0061480957.
Recalling Firm/
Manufacturer
B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact
610-596-0500
Manufacturer 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.
FDA Determined
Cause 2
Material/Component Contamination
Action The firm, BD, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 6/12/2017 to its customers/kit packers. B.Braun Medical Inc. (BBMI), sent a "VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter dated 6/23/2017 to all BBMI customers in receipt of suspect product. Customers were notified by US Postal Service Certified Mail with registered return receipt mail or FedEx Priority. The letters described the product, problem and actions to be taken. The customers were instructed to review the device notification in its entirety and inform all users of the recall; determine your inventory of the affected product-Do not destroy any affected product; complete and return the "Product Removal Acknowledgement" form to B.Braun Medical Inc. Quality Assurance department via fax to 610-849-1197 or email to PA_QualityAssurance.BBMUS_Service@bbraun.com within two 2 weeks of receipt, even if the total inventory in your possession is zero 0; and if you have any full cases, partial cases or unused individual pieces a BBMI Customer Support Representative will contact you to provide instructions for handling affected product and arrange for return. Should you have any questions or concerns regarding the recall, please contact our Customer Support Department at 800-227-2862.
Quantity in Commerce 120 units
Distribution US Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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