Custom Medical Specialties Recalls CT Biopsy Trays with PVP Prep Solution
Custom Medical Specialties is recalling CT biopsy trays containing PVP Prep Solution because the solution lacked microbial testing and did not meet 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, but the source text does not report any illnesses, injuries, or deaths. The hazard is a lack of microbial testing and specification failure, which fits the criteria for a moderate risk where harm is theoretical or precautionary.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 538 cases of CMS-4873 Custom CT Biopsy Trays and CMS-4873-R1 Custom CT Biopsy Trays containing a 4 oz. bottle of PVP Prep Solution. The PVP contained in the kit is used in skin prep.
The recall was initiated after the firm observed an FDA recall for the manufacturer of the Povidone Iodine Prep Solution. The reason for the recall is that the product did not undergo microbial testing and did not meet proper finished goods specifications.
The affected products were distributed nationwide in the United States, including the states of Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey, and Pennsylvania. Affected lot codes include 16661-0909, 16662-0909, 17272-0910, 17566-0911, 17923-1001, 18188-1001, 18195-1001, 18793-1003, and 19158-1004.
The recalled product
- Product
- CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
- Manufacturer
- Custom Medical Specialties, Inc.
- Category
- Medical Device — Biopsy Trays
- Affected units
- 538
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 (9)
- 16661-0909
- 16662-0909
- 17272-0910
- 17566-0911
- 17923-1001
- 18188-1001
- 18195-1001
- 18793-1003
- 19158-1004
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.
See all 12 products in this recall →Related recalls
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