FDA Device recall 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 f…
- FDA Device
- Class II
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class II recall of 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 f… by Genesis Bps, citing genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2669-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-17 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Genesis Bps |
| Distribution | US |
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
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Identifiers
| code_info | Cat #405-535MJ Lot # 3650-23970; 3650-24518; 3650-23477; 3650-23507; 3650-24331; 3650-24396; 3650-24486; 3650-25301 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2669-2014%22
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