Recall Notice: H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing

On August 27, 2011, H & P Industries and the FDA issued a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased. It is advised that healthcare professionals and patients report any adverse health events related to use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting System. Click here for more information.

Recall Notice: Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: Class I Recall

On August 3, 2011, the FDA notified healthcare professionals of a Class I recall of certain Arrow NextStep Antegrade Chronic Hemodialysis Catheters, due to reports of breakage and/or separation of the stylet. These products were distributed to medical facilities and physicians in California, Delaware, Florida, Michigan, North Carolina, and Tennessee. Listed below are the affected product and lot numbers which were manufactured between April 14, 2011 and May 9, 2011.

Product Number Lot Number

CS-15192-IXM RV1034909
CS-15232-IXM RV1034911
CS-15272-IXM RV1034912
CS-15312-IXM RV1034913
CS-15422-IX RV1034914
CS-15502-IX RV1034915

The Arrow NextStep Antegrade Catheter is indicated for use in adult patients for attaining long-term vascular access for hemodialysis and apheresis. Chronic hemodialysis catheters are typically placed into a large vein in the patient's neck. Customers should check their stock, cease use and distribution, and quarantine all affected product. See the Recall Notice for additional information. For questions regarding this recall, contact Arrow International Inc. Customer Service at 1-(800)-233-3187. Click here for more information.