Custom Medical Specialties, Inc.: 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.; 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.

Agency Publication Date: September 20, 2012

Affected Products

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

20182-1006

Product: 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

15011-0904 and 16363-0908

Product: 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

15287-0905, 15974-0906, 17052-0910

Product: 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

14161-0901

Product: 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

20144-1006, 19702-1005

Product: 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

14163-0901

Product: 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

14267-0901, 14452-0902, 15205-0904, 16147-0907, 16690-0909, 17431-0911, 17708-0912, 17913-1001, 18240-1002, 18308-1002, 18345-1002, 18511-1002, 18739-1003, 18829-1003

Product: 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

15924-0906, 16975-0910, 17709-0912

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

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

Product: 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

19134-1004

Product: 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

19850-1006

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

14255-0901

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62132

Status: Resolved

Manufacturer: Custom Medical Specialties, Inc.

Manufactured In: United States

Units Affected: 12 products (5 cases; 3 cases; 6 cases; 3 cases; 7 cases; 75 cases; 195 cases; 15 cases; 538 cases; 4 cases; 8 cases; 75 cases & 60 Bottles for reps)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.