Custom Medical Specialties Recalls Hysteroscopy Kits Due to Microbial Testing Failures
Custom Medical Specialties is recalling BR980-9600 Hysteroscopy Sterile Procedure Kits because the included Povidone Iodine Prep Solution lacked required microbial testing and failed finished goods specifications.
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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. Additionally, the lack of microbial testing in a sterile procedure kit represents a significant risk of infection.
Plain-English summary
Custom Medical Specialties, Inc. is recalling the BR980-9600 Hysteroscopy Sterile Procedure Kit. The recall is triggered by the Povidone Iodine Prep Solution contained within the kit, which was found to have no microbial testing and did not meet proper finished goods specifications.
The firm initiated the recall after observing a related recall by the manufacturer of the Povidone Iodine Prep Solution on the FDA website. The affected product quantity consists of 75 cases and 60 bottles for representatives.
Distribution was US Nationwide, specifically including the states of Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey, and Pennsylvania. The product code is 14255-0901. The PVP contained in the kit is used for skin prep during hysteroscopy procedures.
The recalled product
- Product
- BR980-9600 Hysteroscopy Sterile Procedure Kit 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.
- Category
- Medical Device — Surgical Kits
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)
- 14255-0901
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.
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