Genesis BPS Recalls Pedi-Pak Syringe Filters for Unreported Changes
Genesis BPS is recalling 7,560 units of Pedi-Pak Pedi-Syringe Filters because the company failed to notify the FDA of material changes to the device.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 notification failure rather than a specific safety 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 7,560 units of Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe devices. These 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 affected units were distributed nationwide and in Switzerland.
Healthcare providers and patients should stop using the affected devices immediately. The specific lot numbers involved are 3640-23476, 3640-23506, 3640-24153, 3640-24206, 3640-24398, 3640-24485, 3640-24517, 3640-23969, 3640-24330, and 3640-24521. The catalog number is 405-530BD.
The recalled product
- Product
- 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
- Manufacturer
- Genesis BPS, LLC.
- Affected units
- 7,560
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 (10)
- Cat #405-530BD Lot #3640-23476
- 3640-23506
- 3640-24153
- 3640-24206
- 3640-24398
- 3640-24485
- 3640-24517
- 3640-23969
- 3640-24330
- 3640-24521
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
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