Customed Recalls Neuro Packs Due to Potential Packaging Integrity Compromise
Customed, Inc. is recalling Neuro Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (loss of sterility/contamination) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 12 lots of Neuro Packs, which contain various surgical instruments and supplies. The recall involves 256 units distributed worldwide, including the United States, Puerto Rico, US Virgin Islands, and several international countries.
The recall was initiated because Customed determined that the packaging integrity of the products may be compromised. This defect could result in product contamination or a loss of sterility, which poses a risk of injury to patients.
The affected product is an EO sterilized surgical convenient pack packaged in a polyester/polyethylene breather bag with Tyvek double vents. The source text does not specify specific instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4" X 4" 1 6PLY XRD UF ( I ) CAUTERY POLISHER TIP LIF ( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE (8
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
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 (1)
- Product code 900-2256
Distribution
Part of a larger recall action
This product is one of 233 recalled by Customed, Inc 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 233 products in this recall →Related recalls
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