Custom Medical Specialties Recalls Myelogram Trays with PVP Prep Solution
Custom Medical Specialties is recalling CMS-5284 Custom Myelogram Trays containing PVP Prep Solution because the solution lacked microbial testing and failed to meet finished goods specifications.
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 I by the agency metadata, but the source text explicitly states the hazard is due to lack of testing and specification failure without reporting any illnesses or injuries. Per the rubric, when no illnesses are reported and the hazard is theoretical (lack of testing), the score is capped at 3, but given the specific nature of the defect (specification failure rather than active contamination) and the precautionary nature of the firm's action based on a manufacturer recall, it aligns with Moderate severity for a medical device where no harm is reported.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 8 cases of CMS-5284 Custom Myelogram Trays. These trays contain a 2 oz. bottle of PVP Prep Solution, which is used for skin preparation. The product was distributed nationwide, including in Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey, and Pennsylvania.
The recall was initiated after the firm observed an FDA website notice regarding a recall by the manufacturer of the Povidone Iodine Prep Solution. The source text states that the product was recalled due to a lack of microbial testing and because it did not meet proper finished goods specifications.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled product, nor does it report any illnesses or injuries associated with the use of these trays.
The recalled product
- Product
- CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
- Manufacturer
- Custom Medical Specialties, Inc.
- Affected units
- 8
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)
- 19850-1006
Distribution
Part of a larger recall action
This product is one of 12 recalled by Custom Medical Specialties, 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.
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