Device recall: Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and
Genesis BPS, LLC. (Hackensack, NJ) initiated this device recall on 17 Jul 2014; FDA lists 3 product records under event 68874, classified Class II.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 4 Mar 2016. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Genesis BPS, LLC..
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Genesis BPS, LLC., Hackensack, NJ.
Reason for recall
"Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes."
Distribution
"Nationwide Distribution & Switzerland"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2667-2014 | 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 | 7560 units | Class II | Terminated | 24 Sep 2014 |
| Z-2668-2014 | Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/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 | 7272 units | Class II | Terminated | 24 Sep 2014 |
| Z-2669-2014 | 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. | 4608 units | Class II | Terminated | 24 Sep 2014 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution & Switzerland"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Mar 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.