CLASS I Device recall · Reported 26 Sep 2012 · FDA Enforcement Report

CMS-8457 Hysteroscopic Sterilization Pack containing bottle PVP Prep recalled

Custom Medical Specialties is recalling CMS-8457 Hysteroscopic Sterilization Pack containing bottle PVP Prep, distributed nationwide in the US. The recall was initiated on 30 Sep 2011 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes15011-0904 and 16363-0908

Quantity recalled3 cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2350-2012
FDA event ID: 62132
Recalling firm: Custom Medical Specialties, Pine Level, NC
Classification: Class I
Status: Terminated
Recall initiated: 30 Sep 2011
FDA classified: 20 Sep 2012
Reported: 26 Sep 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

30 Sep 2011	Recall initiated by company
20 Sep 2012	Classified by FDA	+356 days
26 Sep 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep

Where it was distributed

US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.

Nationwide Colorado Florida Kansas Massachusetts Michigan New Jersey Pennsylvania

Questions about this recall

Is CMS-8457 Hysteroscopic Sterilization Pack containing bottle PVP Prep recalled?

Yes. Custom Medical Specialties recalled CMS-8457 Hysteroscopic Sterilization Pack containing bottle PVP Prep on 30 Sep 2011. The recall is Class I and its status is Terminated. Recall number Z-2350-2012.

Why was it recalled?

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.

Which lots are affected?

15011-0904 and 16363-0908

Where was it sold?

US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Custom Medical Specialties

All 21

Reported	Class	Recall	Company	Reason	Where
1 Mar 2017Device	CLASS II	Cms-2193-R7 and Cms-1911-R3 Custom Biopsy Tray recalled	Custom Medical Specialties	Sterility	ID, OR
19 Feb 2014Device	CLASS II	US Probe Cover CMS-6049, Sterile, Single Patient Use recalled	Custom Medical Specialties	Sterility	9 states
26 Sep 2012Device	CLASS I	CMS-5284 Custom Myelogram Tray containing bottle PVP Prep Solution recalled	Custom Medical Specialties	Other	Nationwide
26 Sep 2012Device	CLASS I	CMS-8495-R5 Custom Vein Tray containing bottle PVP Prep Solution recalled	Custom Medical Specialties	Other	Nationwide
26 Sep 2012Device	CLASS I	Cms-8325-R2 Abington Radiology Drainage Pack recalled	Custom Medical Specialties	Other	Nationwide

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