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U.S. Department of Health and Human Services

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Clinipad Corporation Recall - Customer Letter - Mar 2000

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.


This is the retyped text of a letter from Clinipad Corporation. Contact the company for a copy of any referenced enclosures.

March 9, 2000
BY CERTIFIED MAIL

URGENT -- DRUG RECALL

 

Re: Recall of Sterile Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol, and Alcohol Antiseptic Products as Well as Sterile Cliniguard® Protective Dressing, and Specified Lots of Nonsterile Products (Included in the Attached List)

Dear Customer:

This letter is to inform you that The Clinipad Corporation ("Clinipad" or "the company") is voluntarily recalling all Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol and Alcohol Antiseptic products (swabsticks, prep pads, towelettes, and pouches) as well as Cliniguard® Protective Dressing labeled as "sterile" that were manufactured over the last three years. A list of the sterile products involved in this recall is attached. You can identify the products labeled as "sterile" by examining the unit-of-use label which will contain the word "Sterile" or "Sterile unless opened or damaged," as well as by the product description and/or the NDC Number, which appear on the unit-of-use label. The product reorder code, which in all instances does not appear on the unit-of-use label, is included on the attached recall list to facilitate those customers who have the product shipper carton on their shelf or in their warehouse. All lots of "sterile" product involved in this recall have a lot number beginning with "7," "8," "9," or "0." You can identify the lot number by examining the top or side seal of the product pouch, where the lot number is embossed, or the product label where the lot number is stamped; the lot number is also printed on the shipper carton or its label.

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. The company has received no confirmed reports of patient complaints or injuries resulting from these products related to any contamination. Nevertheless, in light of the inability to assure product sterility, Clinipad has decided to voluntarily recall all of its Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol and Alcohol Antiseptic Products as well as Sterile Cliniguard® Protective Dressing labeled as "sterile."

Clinipad also is voluntarily recalling certain lots of its nonsterile products, as identified on the attached list, because the company cannot assure that these products meet their microbial release specifications. The only lots of nonsterile products affected by this recall are identified on the attached list. This recall does not affect any other lots of Clinipad's nonsterile products. You can identify the lot number by examining the top or side seal of the product pouch, where the lot number is embossed, or the product label where the lot number is stamped; the lot number is also printed on the shipper carton or its label.

Please examine your stock immediately to determine if you have any of the recalled products on hand. If so, please 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 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 nonsterile products from your kits, render them unusable, and destroy them promptly in accordance with applicable federal, state, and local laws, regulations, and ordinances.

Please return the enclosed card immediately providing the requested information.

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 posted information on their WEB sites at www.fda.gov/CBER/INFOSHEETS.HTM and www.fda.gov/CBER/RECALLS.HTM which identifies alternative products and procedures that can be used to prepare phlebotomy sites at blood donor centers. Use of the products/procedures listed may be reported in an annual report.

We appreciate your assistance and apologize for any inconvenience that this may cause.

 

Sincerely,

Nelson M. Ford
President and CEO

 

EFFECTIVENESS CHECK CARD

 

PLEASE FILL OUT AND RETURN PROMPTLY

By mail, using the enclosed self-addressed, stamped envelope to
The Clinipad Corporation
175 Capital Blvd.
Rocky Hill, CT 06067

___ We do not have any stock of "Sterile" Clinipad products or nonsterile Clinipad products listed in this recall notice that have not been placed in kits.

___ We had:
____ cases and ____ units of "Sterile" Clinipad products listed in this recall notice that had not been placed in kits and that we have rendered unusable and destroyed.

___ We had:
____ cases and ____ units of "Nonsterile" Clinipad products listed in this recall notice that we rendered unusable and destroyed.

___We do not have any kits containing "Sterile" Clinipad products or nonsterile Clinipad products listed in this recall notice.

___We had___kits containing "Sterile" Clinipad products and ____kits containing nonsterile Clinipad products listed in this recall notice from which we removed, rendered unusable and destroyed the recalled products.

___ We have requested that our accounts render unusable and destroy their stocks of "Sterile" Clinipad products and nonsterile Clinipad products listed in this recall notice.

Date ______________ _______________________________

(Signature)

__________________________________
__________________________________
__________________________________

(Indicate Name, Address and Telephone Number of Person Completing This Notice)

 


 

The Clinipad Corporation
175 Capital Blvd.
Rocky Hill, CT 06067