Medical Devices
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 Name | Lot Number and Expiration Date |
|---|---|
| 1. CMS-4501-R1: Custom HSG Tray containing 2 oz. PVP Prep Bottle | LN: 20182-1006 Exp. Date: 03/2013 |
| 2. CMS-4975: HSG Tray containing 4 oz. bottle PVP Prep Solution | LN: 19134-1004 Exp. Date: 05/2011 |
| 3. CMS-8457: Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep | LN: 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 Solution | LN: 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 Solution | LN: 14161-0901 Exp. Date: 10/2010 |
| 7. CMS-8495-R5: Custom Vein Tray containing 4 oz. bottle PVP Prep Solution | LN: 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 Solution | LN: 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 Solution | LN: 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 Solution | LN: 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 Solution | LN: 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 Solution | LN: 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.
