Custom Medical Specialties Recalls PVP Prep Solution Due to Microbial Testing Failures
Custom Medical Specialties is recalling 75 cases of CMS-8162-R1 Fox Chase Specials Packs containing PVP Prep Solution because the product did not meet finished goods specifications and lacked microbial testing.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, if the agency's own classification is FDA Class I, the score must never go below 4. Therefore, the score is set to 4 (Severe).
Plain-English summary
Custom Medical Specialties, Inc. is recalling 75 cases of the CMS-8162-R1 Fox Chase Specials Pack. These packs contain a 2 oz. bottle of PVP Prep Solution, which is used for skin preparation. The recall was initiated after the firm observed a related recall by the manufacturer of the Povidone Iodine Prep Solution on the FDA website.
The reason for the recall is that the product did not meet proper finished goods specifications and had not undergone microbial testing. The affected units 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 affected product is 14163-0901.
Consumers and healthcare facilities should stop using the affected PVP Prep Solution and contact Custom Medical Specialties, Inc. for further instructions or a refund. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- CMS-8162-R1 Fox Chase Specials Pack 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
- 75
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)
- 14163-0901
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
Same manufacturer · Custom Medical Specialties, Inc.
See all →- HighCustom Medical Specialties Recalls Biopsy Trays with Syringes Due to Sterility Concerns
FDA (Devices) · 2017-03-01
- HighCustom Medical Specialties Recalls Ultrasound Probe Covers for Missing Endotoxin Testing
FDA (Devices) · 2014-02-19
- SevereCustom Medical Specialties Recalls HSG Trays with PVP Prep Solution
FDA (Devices) · 2012-09-26
- SevereCustom Medical Specialties Recalls CT Biopsy Trays with PVP Prep Solution
FDA (Devices) · 2012-09-26
- SevereCustom Vein Tray Recalled for Povidone Iodine Prep Solution Quality Issues
FDA (Devices) · 2012-09-26
Same hazard · microbial contamination
See all →- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- HighCustom Medical Specialties Recalls PVP Prep Solution Due to Lack of Microbial Testing
FDA (Devices) · 2012-09-19
- HighCustom Medical Specialties Recalls Cysto Pack Due to Missing Microbial Testing
FDA (Devices) · 2012-09-19
- HighCustom Medical Specialties Recalls CMS-2890 Needle Local Trays
FDA (Devices) · 2012-09-19
- HighCustom Medical Specialties Recalls Arthrogram Trays Due to Lack of Microbial Testing
FDA (Devices) · 2012-09-19
- ModeratePVP Iodine Prep Pads Recalled for Potency Below Specification
FDA (Drugs) · 2021-09-01
- ModeratePVP Iodine Prep Pads Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2021-09-01