Device recall: CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is…
Class I FDA enforcement event 62132. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
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
Custom Medical Specialties, Inc. started this device recall on 30 Sep 2011. The firm address in the FDA record is in Pine Level, NC. FDA put the recall in Class I. FDA event 62132 has 12 product records. The first FDA enforcement report date is 26 Sep 2012. The record gives the status Terminated, with the termination date 29 Apr 2013.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
Recalling firm
Custom Medical Specialties, Inc., Pine Level, NC.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2349-2012 | 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 | 5 cases | Class I | Terminated | 26 Sep 2012 |
| Z-2350-2012 | 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 | 3 cases | Class I | Terminated | 26 Sep 2012 |
| Z-2351-2012 | CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep | 6 cases | Class I | Terminated | 26 Sep 2012 |
| Z-2352-2012 | CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep | 3 cases | Class I | Terminated | 26 Sep 2012 |
| Z-2353-2012 | CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep | 7 cases | Class I | Terminated | 26 Sep 2012 |
| Z-2354-2012 | CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep | 75 cases | Class I | Terminated | 26 Sep 2012 |
| Z-2355-2012 | CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep | 195 cases | Class I | Terminated | 26 Sep 2012 |
| Z-2356-2012 | CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep | 15 cases | Class I | Terminated | 26 Sep 2012 |
| Z-2357-2012 | 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 | 538 cases | Class I | Terminated | 26 Sep 2012 |
| Z-2358-2012 | CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep | 4 cases | Class I | Terminated | 26 Sep 2012 |
| Z-2359-2012 | CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep | 8 cases | Class I | Terminated | 26 Sep 2012 |
| Z-2360-2012 | 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 | 75 cases & 60 Bottles for reps | Class I | Terminated | 26 Sep 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2011
- 114
- Share of these events in Class I
- 4%
- Product records in this event
- 12Median of the firm: 3
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Sep 2016 | CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Med | Device | Class II | 1 |
| 12 Jul 2013 | 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal ( | Device | Class II | 1 |
| 23 Jul 2012 | Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM | Drug | Class II | 3 |
| 30 Sep 2011 | CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin p | Device | Class II | 4 |
Official channels
- FDA enforcement report Z-2349-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 62132. https://recallregister.com/fda/i/62132/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
- What quantity of product is in FDA event 62132?
- The event has 12 product records. The first record gives this quantity:
5 cases
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2011 have the same class?
- 4% of the 114 device events that started in 2011 are in Class I.