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
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,
Safety Alerts compiles comprehensive safety recall information for
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and timely product warning notification visit: www.safetyalerts.com.