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U.S. Department of Health and Human Services

Medical Devices

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Custom Medical Specialties, Inc., Custom HSG Tray, Hysteroscopic Sterilization Pack, Custom Vein Tray, Custom Amnio Tray, Fox Chase Specials Pack, Abington Radiology Drainage Pack, Custom CT Biopsy Tray, HSG Tray, Custom Myelogram Tray, and Hysteroscopy Sterile Procedure Kit

Recall Class: Class I

Date Recall Initiated: September 30, 2011

Products:

Product NameLot Number and Expiration Date
1. CMS-4501-R1: Custom HSG Tray containing 2 oz. PVP Prep BottleLN: 20182-1006   Exp. Date: 03/2013
2. CMS-4975: HSG Tray containing 4 oz. bottle PVP Prep SolutionLN: 19134-1004   Exp. Date: 05/2011
3. CMS-8457: Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP PrepLN: 15011-0904   Exp. Date: 01/2011
LN: 16363-0908   Exp. Date: 03/2011
4. BR980-9600: Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle
PVP Prep Solution
LN: 14255-0901   Exp. Date: 09/2011
5. CMS-4316: Custom Vein Tray containing 4 oz. bottle PVP Prep SolutionLN: 15287-0905   Exp. Date: 02/2011
LN: 15974-0906   Exp. Date: 03/2011
LN: 17052-0910   Exp. Date: 03/2011
6. CMS-8450-R1: Custom Vein Tray containing 4 oz. bottle PVP Prep SolutionLN: 14161-0901   Exp. Date: 10/2010
7. CMS-8495-R5: Custom Vein Tray containing 4 oz. bottle PVP Prep SolutionLN: 15924-0906   Exp. Date: 07/2011
LN: 16975-0910   Exp. Date: 03/2011
LN: 17709-0912   Exp. Date: 08/2011
8. CMS-2586: Custom Amnio Tray containing 2 oz. bottle PVP Prep SolutionLN: 19702-1005   Exp. Date: 03/2013
LN: 20144-1006   Exp. Date: 03/2013
9. CMS-8162-R1: Fox Chase Specials Pack containing 2 oz. bottle PVP Prep SolutionLN: 14163-0901   Exp. Date: 10/2010
10. CMS-8325-R2: Abington Radiology Drainage Pack containing 4 oz. bottle
PVP Prep Solution
LN: 14267-0901   Exp. Date: 10/2010
LN: 14452-0902   Exp. Date: 10/2011
LN: 15205-9904   Exp. Date: 02/2011
11. CMS-8325-R3: Abington Radiology Drainage Pack containing 4 oz. bottle
PVP Prep Solution
LN: 16147-0907   Exp. Date: 03/2011
LN: 16690-0909   Exp. Date: 04/2011
LN: 17431-0911   Exp. Date: 08/2011
LN: 17708-0912   Exp. Date: 08/2011
LN: 17913-1001   Exp. Date: 09/2011
LN: 18240-1002   Exp. Date: 10/2011
LN: 18308-1002   Exp. Date: 10/2011
LN: 18345-1002   Exp. Date: 11/2011
LN: 18511-1002   Exp. Date: 11/2011
LN: 18739-1003   Exp. Date: 01/2012
LN: 18829-1003   Exp. Date: 01/2012
12. CMS-4873: Custom CT Biopsy Tray containing 4 oz. bottle PCP Prep SolutionLN: 16661-0909   Exp. Date: 01/2012
LN: 16662-0909   Exp. Date: 01/2012
LN: 17272-0910   Exp. Date: 10/2012
13. CMS-4873-R1: Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep SolutionLN: 17566-0911   Exp. Date: 10/2012
LN: 17923-1001   Exp. Date: 09/2012
LN: 18188-1001   Exp. Date: 10/2012
LN: 18195-1001   Exp. Date: 10/2012
LN: 18793-1003   Exp. Date: 11/2012
LN: 19158-1004   Exp. Date: 06/2011
14. CMS-5284: Custom Myelogram Tray containing 2 oz. bottle PVP Prep SolutionLN: 19850-1006   Exp. Date: 01/2013

Use: The PVP (Povidone Iodine Prep) contained in the kit is used in skin prep.

Recalling Firm:
Custom Medical Specialties, Inc.
330 East Main Street
Pine Level, North Carolina 27568

Manufacturer of the Povidone Iodine Prep Solution:
H & P Industries, Inc.
700 W. North Shore Dr.
Hartland, Wisconsin 53029-8358

Reason for Recall: The custom surgical kits contain Povidone Iodine Prep solution that had previously been recalled by H & P Industries, Inc. The manufacturer did not conduct any microbial testing and the products did not meet proper finished specifications. These products may cause serious adverse health consequences, including death.

Public Contact:
Custom Medical Specialties, Inc.
(919) 202-8462

FDA District: Atlanta District Office

FDA Comments: Recall letters were sent on September 27, 2011 to advise them of the recall of Povidone Iodine Prep Solutions manufactured by H & P Industries and distributed by Triad Group. The letter requested that they inspect inventory and return any remaining products.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.