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U.S. Department of Health and Human Services

Class 2 Device Recall YType Blood Administration Set

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  Class 2 Device Recall YType Blood Administration Set see related information
Date Initiated by Firm November 20, 2019
Create Date February 02, 2020
Recall Status1 Terminated 3 on October 16, 2020
Recall Number Z-0935-2020
Recall Event ID 84365
510(K)Number K140311  K922637  
Product Classification Set, administration, intravascular - Product Code FPA
Product Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
Code Information GUIDID: 04046955202799 Lot Numbers:  61679395 - Expiration Date: May 31, 2022, 61685454 - Expiration Date: June 30, 2022
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		 Potential for leakage at the joint between the blood filters and tubing
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 11/20/2019, B Braun Medical Inc. issued Urgent Medical Device letters and Product Removal Acknowledgment forms to customers. On 11/20/2019, B Braun Medical Inc. also issued a press release. Actions Required By BBMI Customer/User: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward a copy of the recall notification to your customers. 2. Determine your current inventory of the affected lots within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the 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. 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 1,824 units
Distribution US Nationwide
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 = FPA and Original Applicant = B. BRAUN MEDICAL, INC.
510(K)s with Product Code = FPA and Original Applicant = MCGAW, INC.
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