FDA Recall, for those of us on IV

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<<FDA posts safety alerts, public health advisories, press releases andother>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 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>>Re: Recall of Sterile Povidone Iodine, Tincture of Iodine, BenzoinTincture,>Acetone Alcohol and Alcohol Antiseptic Products as Well as Sterile>Cliniguard® Protective Dressing, and Specified Lots of NonsterileProducts>(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 thelast>three years. A list of the sterile products involved in this recall is>attached. You can identify the products labeled as " sterile " by examiningthe>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, isincluded>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 " ster>ile " 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 alsoprinted>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 CoagulaseNegative>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 topor>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 alsoprinted>on the shipper carton or its label.>According to our records, your company uses <Clinipad> products ascomponents>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 nonsterileproducts>from your kits, render them unusable, and destroy them promptly inaccordance>with applicable federal, state, and local laws, regulations, andordinances.>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> includethe>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 atWWW.FDA.GOV/CBER/INFOSH>EETS.HTM and WWW.FDA.GOV/CBER/RECALLS.HTM, which identifies alternative>products and procedures that can be used to prepare phlebotomy sites atblood>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 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 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 inthis>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 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 ______________ __________________________________>(Signature)>__________________________________>__________________________________>__________________________________>(Indicate Name, Address and Telephone Number of Person Completing ThisNotice)>>------------------------------------------------------------------------>The <Clinipad Corporation>175 Capital Blvd.>Rocky Hill, CT 06067>