CLASS II Device recall · Reported 24 Sep 2014 · FDA Enforcement Report
Pedi-Pak Pedi-Syringe Filter Becton Dickinson Syringe recalled
Genesis BPS is recalling Pedi-Pak Pedi-Syringe Filter Becton Dickinson, distributed nationwide in the US. The recall was initiated on 17 Jul 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2667-2014
- FDA event ID
- 68874
- Recalling firm
- Genesis BPS, Hackensack, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2014
- FDA classified
- 18 Sep 2014
- Reported
- 24 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 17 Jul 2014 | Recall initiated by company | |
| 18 Sep 2014 | Classified by FDA | +63 days |
| 24 Sep 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Product as listed by the FDA
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
Where it was distributed
Nationwide Distribution & Switzerland
Questions about this recall
Why was it recalled?
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Which lots are affected?
Cat #405-530BD Lot #3640-23476; 3640-23506; 3640-24153; 3640-24206; 3640-24398; 3640-24485; 3640-24517; 3640-23969; 3640-24330; 3640-24521
Where was it sold?
Nationwide Distribution & Switzerland
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 68874This product is part of a recall event; the main page for the event is Pedi-Pak Pedi-Syringe Filter Becton Dickinson/Monoject Syringe recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pedi-Pak Pedi-Syringe Filter Becton Dickinson/Monoject Syringe recalled | Genesis BPS | Other | Nationwide | |
| CLASS II | Pedi-Pak Pedi-Syringe Filter Monoject Syringe recalled by Genesis BPS | Genesis BPS | Other | Nationwide |
More recalls from Genesis BPS
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pedi-Pak Pedi-Syringe Filter Monoject Syringe recalled by Genesis BPS | Genesis BPS | Other | Nationwide |
| Device | CLASS II | Pedi-Pak Pedi-Syringe Filter Becton Dickinson/Monoject Syringe recalled | Genesis BPS | Other | Nationwide |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |