Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis… — Class II medical device recall Z-2669-2014
Terminated recall by Genesis BPS, LLC., reported 2014-09-24, distributed nationwide. Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce mate
| Recall number | Z-2669-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genesis BPS, LLC., Hackensack, NJ, United States |
| Recall initiated | 2014-07-17 |
| Classified | 2014-09-18 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2016-03-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH |
| Quantity | 4,608 units |
| Lot numbers | 3650-23477, 3650-23507, 3650-23970, 3650-24331, 3650-24396, 3650-24486, 3650-24518, 3650-25301 |
| Model numbers | 405-535MJ |
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.
Reason for recall
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2669-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.