Clinipad Corporation Recall - Kit Repacker Letter - Mar 2000
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This is the retyped text of a letter from The Clinipad Corporation. Contact the company for a copy of any referenced enclosures.
March 9, 2000
OEM Kit Packer Label
BY CERTIFIED MAIL
URGENT -- DRUG RECALL
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(r) 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(r) 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.
According to our records, your company uses Clinipad products as components in one or more kits that you manufacture. Please examine your stock immediately to determine if you have any of the recalled Clinipad products. If so, please remove the recalled products from your inventory, render them unusable, and destroy them promptly in accordance with applicable federal, state, and local laws, regulations, and ordinances. Also please remove, render unusable and destroy any of the recalled products from kits that you have manufactured but have not distributed.
If you have distributed any kits containing recalled Clinipad products, please immediately contact your accounts and advise them of this recall. We also recommend that your accounts advise their end-user customers to 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.
We appreciate your assistance and apologize for any inconvenience that this may cause.
Sincerely Nelson M. Ford
President and CEO
By mail, using the enclosed self-addressed, stamped envelope to
___ We do not have any stock stock of "Sterile" Clinipad products or nonsterile Clinipad products listed in this recall notice that have not been placed in kits.
___ We had:
___ We had:
___ 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 remove, render unusable and destroy any "Sterile" Clinipad products and nonsterile Clinipad products listed in this recall notice that are contained in kits among their inventories.
Date ______________ __________________________________
175 Capital Blvd.
Rocky Hill, CT 06067