Genesis BPS Recalls Pediatric Blood Filter Syringes for Regulatory Non-Compliance
Genesis BPS, LLC is recalling 4,608 units of Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringes because the company failed to notify the FDA of material changes.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text cites a regulatory failure to notify the agency of material changes rather than a specific physical defect or reported injury, aligning with the 'Moderate' criteria for voluntary or administrative recalls without reported harm.
Plain-English summary
Genesis BPS, LLC is recalling 4,608 units of Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringes. These prescription-only medical devices are intended to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and neonatal transfusion.
The recall was initiated because the manufacturer did not notify the U.S. Food and Drug Administration of its intent to introduce material changes to the device. The agency has classified this recall as Class II.
The affected units are identified by Catalog Number 405-535MJ and specific lot numbers: 3650-23970, 3650-24518, 3650-23477, 3650-23507, 3650-24331, 3650-24396, 3650-24486, and 3650-25301. The products were distributed nationwide and in Switzerland. Healthcare providers and patients should check their inventory for these specific lot numbers and contact the manufacturer or the FDA for further instructions.
The recalled product
- 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.
- Manufacturer
- Genesis BPS, LLC.
- Affected units
- 4,608
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Cat #405-535MJ Lot # 3650-23970
- 3650-24518
- 3650-23477
- 3650-23507
- 3650-24331
- 3650-24396
- 3650-24486
- 3650-25301
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Genesis BPS, LLC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Genesis BPS, LLC.
See all →- ModerateGenesis BPS Recalls Pediatric Blood Filter Syringes for Regulatory Non-Compliance
FDA (Devices) · 2014-09-24
- ModerateGenesis BPS Recalls Pedi-Pak Syringe Filters for Unreported Changes
FDA (Devices) · 2014-09-24
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