Custom Medical Specialties Recalls Cysto Pack Due to Missing Microbial Testing
Custom Medical Specialties is recalling CMS-8412-R2 Custom Cysto Packs because the manufacturer did not perform required microbial testing, causing the product to fail finished goods 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 is classified as FDA Class II, and the hazard involves a medical device that failed to meet specifications due to missing microbial testing, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Custom Medical Specialties, Inc. is recalling the CMS-8412-R2 Custom Cysto Pack, which contains a 2 oz. bottle of PVP Prep Solution used for skin preparation. The recall involves 3 cases of the product, identified by code 19207-1004.
The recall was initiated after the firm observed an FDA website notice indicating that the manufacturer had not implemented microbial testing. Consequently, the product did not meet proper finished goods specifications. The affected units were distributed nationwide, including in Georgia, Michigan, New York, and Pennsylvania.
Healthcare facilities and consumers who possess this specific product should stop using it and contact Custom Medical Specialties, Inc. for instructions on return or disposal.
The recalled product
- Product
- CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
- Manufacturer
- Custom Medical Specialties, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 3
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)
- 19207-1004
Distribution
Part of a larger recall action
This product is one of 4 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 4 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 Hysteroscopy Kits Due to Microbial Testing Failures
FDA (Devices) · 2012-09-26
- ModerateCustom 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 →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15