Genesis BPS, LLC. Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson 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 Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson 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
Brand
Genesis BPS, LLC.
Lot Codes / Batch Numbers
Cat #405-530BD Lot #3640-23476, 3640-23506, 3640-24153, 3640-24206, 3640-24398, 3640-24485, 3640-24517, 3640-23969, 3640-24330, 3640-24521
Products Sold
Cat #405-530BD Lot #3640-23476; 3640-23506; 3640-24153; 3640-24206; 3640-24398; 3640-24485; 3640-24517; 3640-23969; 3640-24330; 3640-24521
Genesis BPS, LLC. is recalling Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended due to Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026