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U.S. Department of Health and Human Services

Class 2 Device Recall NRFit Perifix 0.2m Filter

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  Class 2 Device Recall NRFit Perifix 0.2m Filter see related information
Date Initiated by Firm July 10, 2019
Create Date September 05, 2019
Recall Status1 Terminated 3 on August 21, 2020
Recall Number Z-2473-2019
Recall Event ID 83478
Product Classification Spinal epidural anesthesia kit - Product Code OFT
Product CE18HKN ACCU-BLOC PERIFIX KIT NRFIT
Catalog # 339189
Code Information Lot # 0061620283  UDI: 04046964943294 
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact Patrick Witmer
610-596-0500
Manufacturer Reason
for Recall		 The filter capacity is not achieved due to damage of the filter membrane.
FDA Determined
Cause 2		 Under Investigation by firm
Action 1. Review the Device Recall Notification entirety and ensure that all users in your organization are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the consumer level. 2. Determine your current inventory of the affected lots within your facility. Do not destroy any affected product. 3. Utilizing the attached, Product Removal Acknowledgement form, record the total number of individual units (within partial cases) and the number of full-unopened cases. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Removal Acknowledgement form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. If you have any full cases, partial cases or unused individual pieces of these affected products as identified in the Product Removal Acknowledgement form that was submitted to BBMI Quality Assurance Department, a BBMI Customer Support Representative will contact you to provide instructions for handling the affected product and arrange for return to BBMI. This may include credit or replacement product. Should you identify product where this issue has occurred, please report the event promptly to BBMI by contacting our Clinical and Technical Support Department at 1-800-854-6851
Quantity in Commerce 200 units
Distribution CA FL MO TX MN AL GA NC IL PA
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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