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U.S. Department of Health and Human Services

Class 2 Device Recall Genesis BPS, LLC

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  Class 2 Device Recall Genesis BPS, LLC see related information
Date Initiated by Firm July 17, 2014
Date Posted September 18, 2014
Recall Status1 Terminated 3 on March 04, 2016
Recall Number Z-2669-2014
Recall Event ID 68874
510(K)Number K050805  
Product Classification Set, blood transfusion - Product Code BRZ
Product Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe
Rx Only Genesis BPS, LLC
The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.
Code Information Cat #405-535MJ Lot # 3650-23970; 3650-24518; 3650-23477; 3650-23507; 3650-24331; 3650-24396; 3650-24486; 3650-25301
Recalling Firm/
Manufacturer		 Genesis BPS, LLC.
65 Commerce Way
Hackensack NJ 07601-6302
For Additional Information Contact Ms. Michelle Kurus
201-488-1174
Manufacturer Reason
for Recall		 Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
FDA Determined
Cause 2		 No Marketing Application
Action Genesis BPS sent an Urgent Medical Device Recall letter with a Recall Letter/Confirmation Form on July 17, 2014 to all affected customers. Customers were asked to immediately examine their inventory and quarantine product subject to recall. In addition, if there is further distribution of the product, customers should be identified and be notified of the recall. Product use should be discontinued and disposed of according to applicable federal regulations and internal protocols. The attached confirmation form should be completed and returned to Genesis by either fax or (201) 708-1104 or e-mail (info@genesisbps.com). Questions can be directed to (201) 708-1400 ext 2004 (9:00 and to 5:00 pm EST). For questions regarding this recall call 201-488-1174.
Quantity in Commerce 4608 units
Distribution Nationwide Distribution & Switzerland
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 = BRZ and Original Applicant = BLOOD PRODUCTS SPECIALTIES LLC
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