Agency classClass IOur severity:Severe FDA (Devices)·Z-2349-2012·Announced 2012-09-26

Custom Medical Specialties Recalls HSG Trays with Povidone Iodine Prep Solution

Custom Medical Specialties is recalling CMS-4501-R1 Custom HSG Trays because the included Povidone Iodine Prep Solution lacked 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 classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications."

Plain-English summary

Custom Medical Specialties, Inc. is recalling 5 cases of CMS-4501-R1 Custom HSG Trays. These trays contain a 2 oz. PVP Prep Bottle, where the PVP (Povidone Iodine) is used for skin preparation. The product was distributed nationwide in the United States, including Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey, and Pennsylvania.

The recall was initiated after the firm identified a recall by the manufacturer of the Povidone Iodine Prep Solution on the FDA website. The source of the issue is that no microbial testing was in place at the manufacturer, and the product did not meet proper finished goods specifications.

The source text does not specify the actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with the use of this product.

The recalled product

Product: CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep
Manufacturer: Custom Medical Specialties, Inc.
Category: Medical Device — Surgical Trays
Hazard: contamination
quality-control
Affected units: 5

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)

20182-1006

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

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 →

Same manufacturer · Custom Medical Specialties, Inc.

See all →

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Custom Medical Specialties Recalls Ultrasound Probe Covers for Missing Endotoxin Testing
FDA (Devices) · 2014-02-19
Severe
Custom Medical Specialties Recalls HSG Trays with PVP Prep Solution
FDA (Devices) · 2012-09-26
Severe
Custom Medical Specialties Recalls CT Biopsy Trays with PVP Prep Solution
FDA (Devices) · 2012-09-26
Severe
Custom Vein Tray Recalled for Povidone Iodine Prep Solution Quality Issues
FDA (Devices) · 2012-09-26

Same hazard · contamination