Agency classClass IOur severity:Severe FDA (Devices)·Z-2357-2012·Announced 2012-09-26

Custom Medical Specialties Recalls CT Biopsy Trays with PVP Prep Solution

Custom Medical Specialties is recalling CT biopsy trays containing PVP Prep Solution because the solution lacked microbial testing and did not meet 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 and product did not meet proper finished goods specifications."

Plain-English summary

Custom Medical Specialties, Inc. is recalling 538 cases of CMS-4873 Custom CT Biopsy Trays and CMS-4873-R1 Custom CT Biopsy 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 recall for the manufacturer of the Povidone Iodine Prep Solution. The reason for the recall is 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. Affected lot codes include 16661-0909, 16662-0909, 17272-0910, 17566-0911, 17923-1001, 18188-1001, 18195-1001, 18793-1003, and 19158-1004.

The recalled product

Product: CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy 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.
Category: Medical Device — Biopsy Trays
Hazard: contamination
lack-of-testing
Affected units: 538

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 (9)

16661-0909
16662-0909
17272-0910
17566-0911
17923-1001
18188-1001
18195-1001
18793-1003
19158-1004

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 →

High
Custom Medical Specialties Recalls Biopsy Trays with Syringes Due to Sterility Concerns
FDA (Devices) · 2017-03-01
High
Custom Medical Specialties Recalls Ultrasound Probe Covers for Missing Endotoxin Testing
FDA (Devices) · 2014-02-19
Severe
Custom Vein Tray Recalled for Missing Microbial Testing
FDA (Devices) · 2012-09-26
Severe
Custom Vein Tray Recalled for Povidone Iodine Prep Solution Quality Issues
FDA (Devices) · 2012-09-26
Severe
Custom Medical Specialties Recalls Hysteroscopy Kits Due to Microbial Testing Failures
FDA (Devices) · 2012-09-26

Same hazard · contamination