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SafetyAlerts
March 11, 2000

Clinipad Issues Urgent Recall of Sterile and Non-Sterile Products

Rocky Hill, CT  (SafetyAlerts) - The Clinipad Corporation is voluntarily recalling Clinipad sterile-products line including Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol and Alcohol Antiseptic Products, as well as Sterile Cliniguard Protective Dressing Labeled as "sterile," manufactured since Jan. 1, 1997.

Updated Product Discription

The products (swabsticks, prep pads, towelettes, ointments and pouches, as well as protective dressings) are distributed under the names: Cliniswab, Clinipad, Clinidine, Cliniguard, EZ Prep, Cooper Instrument Corp., Moore Medical Corp., and Rauscher. They are sold separately or packaged in various institutional kits and are widely distributed to blood banks, hospitals, clinics, and retail pharmacies and are used to control and prevent infection.

Clinipad also is voluntarily recalling certain lots of its non-sterile products because the company cannot assure that these products meet their microbial release specifications.

The reason for this recall is that the company has confirmed microbial contamination in some lots of its sterile products, including one lot with Pseudomonas aeruginosa, Stenotrophomonas maltophilia, and Coagulase Negative Staphylococcus which was recalled in December 1999.

The potential for microbial contamination exists and we are unable to assure the sterility of products labeled and sold as sterile. This situation represents a potential public health hazard.

Click here for a list of the recalled sterile products.

Click here for a list of the recalled non-sterile products.

The company has received no confirmed reports of patient complaints or injuries resulting from these products related to any contamination.

Clinipad requests that users examine their stock immediately to determine if they have any of the recalled products on hand.  If so, users should discontinue distribution or use of these products, render them unusable, and destroy them promptly in accordance with applicable federal, state, and local laws, regulations, and ordinances.

If companies have distributed any of the recalled products, please immediately contact your accounts, advise them of this recall, have them discontinue distribution or use of these products, render them unusable, and destroy them promptly in accordance with applicable federal, state, and local laws, regulations, and ordinances.

If you are an end-user kit customer, discontinue use of any recalled Clinipad "sterile" and non-sterile products from your kits, render them unusable, and destroy them promptly in accordance with applicable federal, state, and local laws, regulations, and ordinances.

Clinipad is making this recall with the knowledge of the Food and Drug Administration, which has specifically requested that Clinipad include the following statement in this recall letter

To assist blood banks in developing alternative arm preparation procedures, the Food and Drug Administration, Center for Biologics Evaluation and Research, has provided information on which identifies alternative products and procedures that can be used to prepare phlebotomy sites at blood donor centers.

Notice of this product warning was sent via email to SafeMail subscribers March 11, 2000.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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Safety Alerts compiles comprehensive safety recall information for the United States. SafeMail is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.