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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun

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  Class 2 Device Recall B. Braun see related information
Date Initiated by Firm February 07, 2022
Create Date March 22, 2022
Recall Status1 Terminated 3 on December 28, 2023
Recall Number Z-0819-2022
Recall Event ID 89660
510(K)Number K092313  K172831  K191910  
Product Classification Pump, infusion, pca - Product Code MEA
Product PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions
Catalog Number: 8713030U
Code Information Serial Numbers: 633299, 633307, 633310, 633313, 633315, 633318 GUIDID: 04046963716745
Recalling Firm/
Manufacturer		 B Braun Medical Inc
200 Boulder Dr
Breinigsville PA 18031-1532
For Additional Information Contact SAME
610-266-0500
Manufacturer Reason
for Recall		 Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
FDA Determined
Cause 2		 Under Investigation by firm
Action BBraun issued "URGENT MEDICAL DEVICE CORRECTION" letter on 2/7/21 to End-Users. Letter states reason for recall, health risk and action to take: 1. Review the Device Correction Notification in its entirety and ensure that all users in your organization of theabove-mentioned product, and other concerned persons are informed about this voluntary correction. 2. Identify your current inventory of the affected serial (s) within your facility, cease use and quarantine product subject to correction. Do not destroy any affected product. 3. Utilizing the attached Product Correction Acknowledgement form, record the total number of individual units. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Correction 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. Once we have received your acknowledgement a BBMI representative will contact you to arrange for inspection and/or correction of the affected products. Should an issue occur, please report the event promptly to BBMI by contacting Medical Affairs Department at 1-800-854-6851.
Quantity in Commerce 6 units
Distribution US Distribution to states of: MA, VT
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.
510(K) Database 510(K)s with Product Code = MEA and Original Applicant = B. BRAUN MEDICAL, INC.
510(K)s with Product Code = MEA and Original Applicant = B. Braun Melsugen AG
510(K)s with Product Code = MEA and Original Applicant = B.Braun Medical Inc
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