Custom Medical Specialties Recalls HSG Trays with PVP Prep Solution
Custom Medical Specialties is recalling CMS-4975 HSG Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet specifications.
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 medical device where the product failed to meet finished goods specifications and lacked microbial testing. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 4 cases of CMS-4975 HSG 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 website notice regarding a recall by the manufacturer of the Povidone Iodine Prep Solution. The source text states 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. The specific code for the recalled items is 19134-1004.
The recalled product
- Product
- CMS-4975 HSG 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.
- Affected units
- 4
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)
- 19134-1004
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.
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