July 26, 2000 00-30RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Archway brand Gourmet Rocky Road Cookies, in 12-ounce retail packages. Recall #F-605-0. CODE Product dated JUNE 5 through AUG 25. MANUFACTURER Archway Cookies, Inc., Ashland, Ohio and Boone, Iowa. RECALLED BY Archway Cookies, Inc., Ashland, Ohio, by telephone, fax, and press release on June 14, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 6,785 cases (136,696 retail packages) were distributed. REASON Product contains undeclared powdered eggs. ________ PRODUCT Mung Bean Sprouts, in 5 and 10-pound bulk bags, and in 12 and 16-ounce consumer size bags. Recall #F-619-0. CODE All product on the market at the time of recall initiation. MANUFACTURER Pacific Coast Sprout Farms, Inc., Sacramento, California. RECALLED BY Manufacturer, by letter, visit, fax, telephone, e-mail, television and radio announcements beginning on April 18, 2000. A news release was issued by California Department of Health Services (CDHS) dated April 19, 2000, and subsequent press releases by the firm to Oregon and Nevada. Firm-initiated recall complete. DISTRIBUTION Nevada and Oregon. QUANTITY Firm estimates none remains on the market. REASON Product was epidemiologically linked with a Salmonella Enteritidis outbreak. ________ PRODUCT Astragulus Capsules, 500 mg, in bulk containers of 10,000 capsules, a botanical dietary supplement. Recall #F-620-0. CODE Lot #21592. MANUFACTURER ABS Corporation, doing business as Eudaemonic Corporation, Omaha, Nebraska. RECALLED BY Manufacturer, by telephone on September 2, 1999. Firm-initiated recall complete. DISTRIBUTION North Dakota. QUANTITY 235,872 capsules were distributed. REASON Product was contaminated with Salmonella.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Minute Maid Juice Bars, 12-pack, 2.25-fluid ounces. Recall #F-606-0. CODE "BEST BY FEB2901" through "BEST BY APR 1501". MANUFACTURER Mia Products Company, Moosic, Pennsylvania. RECALLED BY J&J Snack Foods Corp., Pennsauken, New Jersey, by press release and letter on May 15, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 25,135 cases were distributed; firm estimated that 4,500-5,000 cases remained on market at time of recall initiation. REASON Product is contaminated with pieces of polyethylene. ________ PRODUCT Keebler Fudge Shoppe Mini Fudge Stripe Cookies, snack size fudge covered shortbread cookies packaged in 2-ounce laminated pouches. Recall #F-607-0. CODE Product code dates AL07010 through AL12090 (other letters may follow the code dates). MANUFACTURER Laurel Cookie Factory, London, Kentucky (cookies); Bloomer Chocolate Company, Inc., Chicago, Illinois (coating). RECALLED BY Keebler Company, Elmhurst, Illinois, by letter on June 26, 2000. The recall information was sent to the Food Allergy Network, both as an electronic message and a mailing to all Food Allergy Network members. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 300,000 cases were distributed. REASON The chocolate coating component of the cookies contains milk residue.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT CVS Gold Emblem and Safeway Select brands of Natural Spring Water, in 1.5 liter plastic bottles. Recall #F-608-0. CODE All lot numbers include "PRO110299" followed by 3 or 4 numbers, followed by the letter "S". MANUFACTURER Saratoga Springs Water Company, Saratoga Springs, New York. RECALLED BY Saratoga Beverage Group, Inc., Saratoga Springs, New York, by telephone on or about June 6, 2000, followed by letter. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 4,954 cases (12 per case) were distributed. REASON Product is contaminated with yeast, mold, and particulates.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT JPI Jones Daniels Pharmaceuticals Levoxyl (Levothyroxine Sodium Tablets), 75 mcg (0.075 mg), Rx, packaged in unit-dose strips 10/10-tablet strips per box. Recall #D-434-0. CODE Lot #6221 EXP 02/01. MANUFACTURER Daniels Pharmaceuticals, St. Petersburg, Florida. RECALLED BY Jones Pharma, Inc., St. Louis, Missouri, by telephone on May 8, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 440 10/10-tablet strip boxes were distributed. REASON Mislabeling - The milligram conversion on the unit blisters is incorrectly declared as 0.75 mg. ________ PRODUCT Sodium Edecrin(r) Intravenous (Ethacrynate sodium), 50 mg, single dose vial, Rx indicated for the treatment of edema. NDC #0006-3620-50. Recall #D-435-0. CODE Lot Numbers: 1398J EXP 6/01, 0564K EXP 8/01, 0462K EXP 9/01. MANUFACTURER Merck and Company, West Point, Pennsylvania. RECALLED BY Manufacturer, by letter dated June 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Germany, and Israel. QUANTITY 16,712 units were distributed. REASON pH failure (six month stability).RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
________ PRODUCT Platelets, Pheresis. Recall #B-858-0. CODE Unit #3758162. MANUFACTURER Southwest Oklahoma Blood Institute, Lawton, Oklahoma (collection site). RECALLED BY Oklahoma Blood Institute, doing business as Sylvan N. Goldman Center Oklahoma Blood Institute, Oklahoma City, Oklahoma, by fax on October 20, 1998. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON The first half of a split Platelets, Pheresis unit implicated in a transfusion fatality, was found to be contaminated with E.coli. The second half of the unit was distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Platelets. Recall #B-877-0. CODE Unit #22KX31026. MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone on May 5, 2000, and by letter on May 10, 2000. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of clotted red blood cells. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-880/881-0. CODE Unit #0334282. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by letter on April 12, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state and Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of Multiple Sclerosis. ________ PRODUCT Red Blood Cells. Recall #B-882-0. CODE Unit #22407-0232. MANUFACTURER Blood Services, Inc., Las Vegas, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated July 20, 1999, and September 7, 1999. Firm-initiated recall complete. DISTRIBUTION Nevada. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported having lived in an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-883/884-0. CODE Unit #22407-8920. MANUFACTURER Blood Services, Inc., Las Vegas, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 14, 1999. Firm-initiated recall complete. DISTRIBUTION Nevada. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-890-0. CODE Unit Numbers: 22409-6408 and 22406-6072. MANUFACTURER Blood Services, Inc., Las Vegas, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated December 21, 1999, and February 4, 2000. Firm-initiated recall complete. DISTRIBUTION Nevada. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells, Leukoreduced, Irradiated. Recall #B-891-0. CODE Unit #8959423. MANUFACTURER New York Blood Services (Center West), A Division of New York Blood Center, Inc., New York, New York. RECALLED BY Manufacturer, by telephone on September 10, 1999, and by letter dated May 15, 2000. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood product tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBc). ________ PRODUCT Red Blood Cells. Recall #B-892-0. CODE Lot #21FM58807. MANUFACTURER American Red Cross, Portland, Oregon. RECALLED BY Manufacturer, by letter dated April 20, 2000. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-893/894-0. CODE Unit Numbers: a) 22404-9139 and 22406-0608; b) 22404-9139. MANUFACTURER Blood Services, Inc., Las Vegas, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated May 11, 1999, and July 13, 1999. Firm-initiated recall complete. DISTRIBUTION Arizona and Nevada. QUANTITY a) 2 units; b) 1 unit. REASON Blood products were collected who reported travel to an area designated as endemic for malaria. ________ PRODUCT Whole Blood. Recall #B-895-0. CODE Unit Numbers: 16348-3676 and 16348-3679. MANUFACTURER United Blood Services, Blood Systems, Inc., Meridian, Mississippi (processor); Blood Systems, Inc., Jackson, Mississippi (Collection Site). RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on June 1, 1999. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 2 units were distributed. REASON Blood products were mislabeled as CMV antibody negative. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-900/901-0. CODE Unit #22GK72646. MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone on February 29, 2000, and by letter dated March 3, 2000. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for anti-HCV, but were collected from a donor who previously tested repeatedly reactive for anti-HCV. ________ PRODUCT Red Blood Cells. Recall #B-909-0. CODE Unit #42FQ85736. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated May 4, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Recovered Plasma. Recall #B-911-0. CODE Unit #22LN63673. MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by forwarding a "Questionable Plasma Inquiry" on September 3, 1999. Firm-initiated recall complete. DISTRIBUTION Switzerland. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of hepatitis B. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced. Recall #B-915/916-0. CODE Unit Numbers: a) 21GL43397; b) 21GL50316. MANUFACTURER American Red Cross, Portland, Oregon. RECALLED BY Manufacturer, by letter dated April 20, 2000. Firm-initiated recall complete. DISTRIBUTION Oregon and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the drug Methotrexate. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-922/924-0. CODE Unit Numbers: a) 1213460; b) 1211264 and 1213460; c) 1211264. MANUFACTURER Carter Blood Care, Bedford, Texas. RECALLED BY Manufacturer, by letter dated June 29, 1999. Firm-initiated recall complete. DISTRIBUTION Texas and California. QUANTITY a) 1 unit; b) 2 units; c) 1 unit was distributed. REASON Blood products were collected from a donor with a history of high risk behavior. ________ PRODUCT Red Blood Cells. Recall #B-925-0. CODE Unit Numbers: 22KJ42198, 22KJ42713, 22KZ28850, and 22LV59553. MANUFACTURER The American National Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone on May 14, 1999, and by letter dated May 23, 1999. Firm-initiated recall complete. DISTRIBUTION New Jersey and Pennsylvania. QUANTITY 4 units were distributed. REASON Blood products were either untested for Cytomegalovirus (CMV) or tested CMV positive, but were labeled as negative for CMV. _______ UPDATE Recall #B-865/867-0, Red Blood Cells, Leukoreduced; Platelets; and Recovered Plasma (American Red Cross Blood Cross, Nashville, Tennessee), which appeared in the July 12, 2000 Enforcement Report should read: CODE Unit #19GF72679.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-898-0. CODE Unit #FC00025. MANUFACTURER Southern Blood Services, Inc., Nashville, Tennessee. RECALLED BY Manufacturer, by telephone on May 12, 2000, and by letter dated May 15, 2000. Firm-initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 1 unit was distributed. REASON Leukoreduced red blood cells that failed red cell recovery ratio. _______ PRODUCT Red Blood Cells. Recall #B-899-0. CODE Unit #22KY40612. MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone on January 19, 2000, and by letter dated January 24, 2000. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose arm inspection had not been documented.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Neostar Dialysis Catheter Kits and Central Venous Catheter Kits under the following labels: Neostar Chronic Dual Lumen Catheter Kit - Product Code Numbers AC-190K, AC-190KC, AC-190KC-WING, AC-230K, AC-230KC, AC-230KCAL, AC-230KC-WING, AC-230KC-WINGED, AC-270K, AC-270K-WING, AC-280KC, AC-280KC-TV01, AC/DLC- 190KC. Neostar Chronic Catheter Placement Kit - Product Code Number AC-K, AC-KC Neostar Acute CAVH Catheter Kit - Product Code Numbers CAVH-1045K, CAVH- 1060K, CAVH-945K, CAVH-960K Neostar Dual Lumen CV Tunneled Catheter Kit - Product Code Numbers CV- 111K, CV-112K, CV-221K, CV-222K, CV-223K, CV-224K Neostar Triple Lumen CV Tunneled Catheter Kit - Product Code Number CV- 331K Pheres Flow Triple Lumen Catheter Kit - Product Code Numbers CV-332AK, CV-332BK, CV-332K, CV-332K-NE01, CV-332K-NE02 Neostar Acute Dual Lumen Catheter - Product Code Numbers DLC-400KJ, DLC- 500K, DLC-500KC, DLC-500KEC, DLC-500KJ, DLC-511KC, DLC-511KEC, DLC-511KJ, DLC-600K, DLC-600KC, DLC-600KC-AL, DLC-600KC-D101,DLC-600KC-H001, DLC- 600KC-SU02, DLC-600KEC, DLC-600K-EC01, DLC-600KJ, DLC-600KLC, DLC-700KC, DLC-700KC-AM01, DLC-700KEC, DLC-700KJ, DLC-800K, DLC-800KC, DLC-800KC-AL, DLC-800KC-D101, DLC-800KC-D102, DLC-800KC-H002, DLC-800KC-HY02, DLC- 800KEC, DLC-800K-EC01, DLC-800KEC-AL, DLC-800KJ, DLC-800KJC Neostar Peritoneal Insertion Kit - Product Code Numbers PC-K, PC-K-HY01, PC-K-HY02 Neostar Acute Single Lumen Catheter Kit - Product Code Numbers SLFC- 1500K, SLFC-2400K, SLJC-1300K, SLJC-1700K, SLSC-1500K, SLSC-2000K. . Recall #Z-859/860-0. CODE Neostar Chronic Dual Lumen Catheter Kit - Lot Numbers - AT461, AU145, AU191, AU319, AU356, AU385, AV131, AV161, AV205, AV235, AV274, AV330, AV348, AV373, AV381, AV399, AV423, SE97188, SE97240, SE97288, SE98066-1, SE98123, SE98300, SE98323, SE98326, SE98334, AT446, AT462, AT563, AU185, AU202, AU238-1, AU241, AU263, AU289, AU305, AU358, AU386, AV122, AV150, AV165, AV193, AV198, AV206, AV236, AV260, AV275, AV298, AV312, AV325, AV359, AV368, AV387, AV406, AV427, AV431, SE96023, SE97009, SE97037, SE97119, SE97144, SE97151, SE97156, SE97201, SE97215, SE97234, SE97243, SE97248, SE97250, SE97258, SE97297, SE97302, SE97325, SE97329, SE98022, SE98031, SE98035, SE98047, SE98058, SE98063, SE98065, SE98098, SE98108, SE98133, SE98142, SE98146, SE98147, SE98148, SE87175, SE98184, SE98194, SE98197, SE98198, SE98200, SE98210, SE98217, SE98223, SE98227, SE98231, SE98233, SE98234, SE98238, SE98239, SE98245, SE98253, SE98276, SE98278, SE98285, SE98286, SE98290, SE98327, SE98396, SE98399, SE98403, SE98417, SE98421, SE98422, SE98470, SE98475, SE98479, SE98484, SE98497, SE98506, SE98518, SE98522, SE99014, SE99021, SE99022, SE99049, SE99055, SE99060, SE99067, SE99092, SE99094, SE99095, SE99122, SE99142, SE99152, SE99175, SE99177, SE99193, SE99195, SE99199, SE99202, SE99213, SE99227, SE99234, SE99239, SE99257, SE99265, SE99274, AU146, AU192-1, AU243, AU281, AU316- 1, AU384, AV132, AV160, AV207, AV296, SE97076, SE97203, SE97205, SE98117, SE98122, SE98301, SE98472, SE99010, SE99020, SE99041, AT444, AT463, AT564, AU142, AU198, AU264, AU297, AU306, AU333, AU359, AU387, AV125, AV163, AV166, AV189, AV208, AV237, AV276, AV297, AV311, AV323, AV337, AV363, AV390, AV407, AV408, AV428, AV439, SE96024, SE97010, SE97032, SE97053, SE97120, SE97136, SE97150, SE97172, SE97191, SE97221, SE97229, SE97232, SE97233, SE97245, SE97249, SE97259, SE97294, SE97298, SE97309, SE98005, SE98021, SE98036, SE98042, SE98046, SE98061, SE98111, SE98118, SE98130, SE98149, SE98162, SE98170, SE98182, SE98186, SE98189, SE98203, SE98209, SE98221, SE98228, SE98235, SE98236, SE98240, SE98243, SE98247, SE98275, SE98277, SE98287, SE98307, SE98316, SE98322, SE98400, SE98405, SE98408, SE98411, SE98418, SE98420, SE98423, SE98429, SE98438, SE98446, SE98474, SE98482, SE98487, SE98488, SE98494, SE98505, SE98509, SE98516, SE99017, SE99026, SE99027, SE99032, SE99056, SE99066, SE99068, SE99087, SE99102, SE99106, SE99113, SE99114, SE99116, SE99118, SE99128, SE99133, SE99138, SE99141, SE99143, SE99182, SE99185, SE99218, SE99238, SE99258, SE99302, AV266, AV202, SE97152, SE97157, SE97184, SE97209, SE97211, SE97322, SE98013, SE98062, SE98115, SE98138, SE98140, SE98145, SE98176, SE98181, SE98187, SE98344, SE98397, SE98401, SE98460, SE98467, SE98499, SE98515, SE99003, SE99008, SE99031, SE99033, SE99036, SE99043, SE99088, SE99093, SE99151, SE99181. Neostar Chronic Catheter Placement Kit - Lots SE97199, SE98391, AU389, AV190, AV272, SE97018, SE97050, SE97158, SE97212, SE98001, SE98015, SE98016, SE98125, SE98134, SE98190, SE98193, SE98260, SE98390, SE98468, SE98469, SE98473, SE98496, SE98502. Neostar Acute CAVH Catheter Kit - Lots AT542, AU195, AU267, AV196, AV251, AV295, AV388, SE97093-1, SE97163-1, SE98432, SE98434, AT546, AU288, AT469, AV133, AV178, AV209, AV177, AV248, SE97227. Neostar Dual Lumen CV Tunneled Catheter Kits - Lots AT484, AT531, SE97100, SE97206, SE99121, SE99124, SE99209, SE99303, SE97101, SE97166, AU171-1, SE97214, SE97228, SE98312, SE97230, AV238, SE96031, SE97043, SE97124, SE97241, AU174-1, AV121, SE97125, SE97208, SE97318, SE98333. Neostar Triple Lumen CV Tunneled Catheter Kits - Lots AT456-1, SE97049, SE97132, SE97225, SE97256, SE98295, SE98313, SE99153, SE99277, SE99304. Pheresis Flow Triple Lumen Catheter Kits - Lots AT440, AT540, AT441, AT541, AU287, AV119, AV151, AV197, AV201, AV210, AV258, AV290, AV313, AV321, AV386, AV402, AV415, AV426, SE96014, SE97011, SE97036, SE97067, SE97089, SE97121, SE97138, SE97147, SE97164, SE97178, SE97207, SE97216, SE97231, SE97246, SE97247, SE97283, SE97293, SE97304, SE97310, SE97323, SE97324, SE97330, SE98006, SE98014, SE98032, SE98034, SE98039, SE98043, SE98044, SE98048, SE98102, SE98103, SE98143, SE98164, SE98166, SE98173, SE98188, SE98191, SE98195, SE98199, SE98211, SE98215, SE98224, SE98225, SE98237, SE98241, SE98248, SE98250, SE98254, SE98255, SE98262, SE98263, SE98264, SE98265, SE98272, SE98281, SE98284, SE98288, SE98315, SE98325, SE98350, SE98386, SE98394, SE98402, SE98404, SE98409, SE98437, SE98444, SE98448, SE98450, SE98461, SE98465, SE98476, SE98483, SE98491, SE98493, SE98498, SE98501, SE98503, SE98508, SE98510, SE98513, SE98519, SE08521, SE99001, SE99034, SE99052, SE99054, SE99058, SE99065, SE99069, SE99078, SE99100, SE99117, SE99162, SE99184, SE99196, SE99198, SE99219, SE99297. Neostar Acute Dual Lumen Catheter Kits - Lots AT186, AV113-1, AU169, AT205, AT470, AT496, AU269, SE97175-1, SE98463, AT110, AT181, AT209, AT214, AT315, AR321-1, AT471, AT569, AT443, AT465, AT520, AT552, AU139, AU159, AU181, AU204, AU214, AU231, AU251, AU253, AU274, AU315, AU323, AU349, AU364, AU373, AU375, AV115, AV144, AV174, AV184, AV188, AV211, AV233, AV239, AV253, AV254, AV268, AV273, AV299-1, AV303, AV316, AV318, AV335, AV358, AV385, AV397, AV400, AV420, SE7024-1, SE97057, SE97074, SE97077, SE97103, AV97104, SE97113, SE97114, SE97139, SE97148, SE97153, SE97220, SE97269, SE97270, SE97284, SE97285, SE98029, SE98030, SE98078, SE98079, SE98091, SE98101, SE98104, SE98109, SE98110, SE98153, SE98165, SE98381, SE98382, SE98426, SE98428, SE98439, SE98440, SE98459, SE98492, SE98495, SE98500, SE98504, SE98514, SE99015, SE99025, SE99028, SE99030, SE99098, SE99104, SE99119, SE99161, SE99172, SE99201, SE99221, SE99306, AT521, AU160, AU161, AU182, AU205, AU254, AU310,AU325, AU350, AU396, AV116, AV148, AV175, AV185, AV212, AV240, AV247, AV293, AV310, AV384, AV392, SE97033, SE97058, SE97082, SE97112, SE97141, SE97160, SE97263, SE97278, SE97286, SE97287, SE97316, SE98045, SE98055, SE98067, SE98077, SE98087, SE98090, SE98160, SE98183, SE98201, SE98204, SE98207, SE98208, SE98213, SE98268, SE98270, SE98283, SE98354, SE98520, SE99029, SE99073, SE99076, AT114, SE98489, SE99144, SE99163, SE99165, SE99166, SE99189, SE99214, SE99225, SE99231, SE99237, SE99245, SE96019-1, SE97042, SE97183, SE97222, AS530, AT111, AT182, AT210, AT213, AT314-1, AT320-1, AT459-1, SE96016, AT467, AT551, AT568, AU127-1, AU156, AU178, AU206, AU208, AU232, AU252, AU276, AU314, AU327, AU352, AU374, AU376, AV117, AV145, AV169, AV186, AV213, AV234, AV241, AV252, AV256, AV270-1, AV294-1, AV306-1, AV317, AV319, AV334, AV353, AV383, AV396, AV414, AV421, SE96017, SE97030, SE97059, SE97084, SE97105, SE97106, SE97111, SE97134, SE97145, SE97146, SE97159, SE97219, SE97265, SE97272, SE97300, SE97301, SE97332, SE98038, SE98071, SE98072, SE98081, SE98083, SE98084, SE98085, SE98089, SE98095, SE98144, SE98150, SE98152, SE98168, SE98226, SE98371, SE98375, SE98379, SE98441, SE98447, SE98449, SE99004, SE99006, SE99016, SE99023, SE99035, SE99050, SE99071, SE99096, SE99103, SE99108, SE99120, SE99167, SE99180, SE99183, SE99186, SE99197, SE99200, SE99222, AU157, AU162, AU179, AU201, AV118, AV147, AV170, AV171, AV214, AV242, AV269, AV309, AV329, AV333, AV374, AV391, SE97025-1, SE97055, SE97085, SE97107, SE97117, SE97140, SE97161, SE97264, SE97266, SE97274, SE97281, SE97306, SE97315, SE87317, SE97319, SE98004, SE98023, SE98070, SE98080, SE98093, SE98151, SE98161, SE98192, SE98214, SE98216, SE98249, SE98261, SE98269, SE98273, SE98282, SE98337, SE98351, SE98523, SE99002, SE99057, AT180, AT475, SE99150, SE99155, SE99156, SE99168, SE99187, SE99205, SE99215, SE99223, SE99264 Neostar Peritoneal Insertion Kit - Lots AU144, AU307, AU337, AU388, AV320, AV357, AV389, SE96025, SE97004, SE97118, SE97200, SE97296, SE98002, SE98041, SE98251, SE98392, SE98412, AV112, AV162, AV225, AV243. Neostar Acute Single Lumen Catheter Kits - Lots AV172, AV250, AV308, AV376, SE96028, SE97013, SE97040, SE97202, SE97217, SE97223, SE97260, SE97262, SE97303, SE98128, SE98158, SE98291, AT516, SE96015, SE97034, SE97128, SE97236, SE98353, AU292, AV153, AV371, SE96029, SE97014, SE97035, SE97061, SE98177, AV158, AV398, SE96030, SE97015, SE97045, SE97062, SE97102, SE98167, SE98178, SE98360. MANUFACTURER Horizon Medical Products, Manchester, Georgia. RECALLED BY Manufacturer, by letter on September 8, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Excess of 100,000 units. REASON The device package may contain pinholes. ________ PRODUCT Narkomed MRI Anesthesia System, gas machine for anesthesia. Recall #Z- 866-0. CODE All units shipped prior to June 7, 2000. MANUFACTURER North American Drager, Telford, Pennsylvania. RECALLED BY Manufacturer, by letter on June 26, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide, Canada, Egypt, Hong Kong, Israel, Puerto Rico. QUANTITY 122 units were distributed. REASON Fresh gas delivery to the vaporizer is reversed resulting in fresh gas flowing backwards through the vaporizer. ________ PRODUCT Medtronic Mosaic(r) Procine Bioprosthesis: a) Medtronic Mosaic Aortic Valves, Model Nos. 30519, 30521, 30523, 30525, 30527; b) Medtronic Mosaic Mitral Valves, Model Nos. 31025, 31027, 31029, 31031, 31033. Recall #Z-867/868-0. CODE Each bioprosthesis carries an individual serial number. They are too numerous to list. MANUFACTURER Medtronic Heart valves, Santa Ana, California. RECALLED BY Manufacturer, by letter May 1, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 529 units were distributed. REASON A misinterpretation in measurement of coaptation depth by a technician resulted in the release of out-of-specification devices. ________ PRODUCT Intraocular Lenses: Basic Phakic AC-50 refractive lens was the first model produced in 1995 and was subsequently replaced by ACN-60 and ACP-60 in 1996. a) Anterior Chamber Negative ACN-60) lenses for myopic correction (with or without serial numbers assigned); b) Anterior Chamber Positive (ACP-60) lenses for hyperopic correction (with or without serial numbers assigned); c) Phakic 6 Refractive Anterior Chamber Lens for both myopic and hyperopic powers (with/without heparin coating and with/without serial numbers assigned). Recall #Z-869/871-0. CODE There are 156 lenses affected, some are assigned a serial number and some are not. The large number of affected units preclude their being listed here. MANUFACTURER Ophthalmic Innovations International, Inc., Claremont, California. RECALLED BY Manufacturer, by letter the week of June 26 to 30, 2000. Firm-initiated recall ongoing. DISTRIBUTION Undetermined. QUANTITY 155 lenses were implanted. REASON The firm failed to obtain an approved IDE (investigational device exemption or PMA (premarket approval). ________ PRODUCT a) OSF-2 Suction Barb Assembly, for use in kit #C1411 QCK; b) Flow Adaptor Sub-assembly, for use in kit #C1440 QCK; c) Quick Connect Kit, #C1411, for use on Olympus OSF-2 Flexible Sigmoidoscope. Recall #Z-872/874-0. CODE Steris Catalog/Part Numbers for the affected 3 devices are: 200367, 200587, and C1411. The Steris Part Number for the defective restrictor component is: 400402. MANUFACTURER Steris Corporation, Mentor, Ohio. RECALLED BY Manufacturer, by telephone on May 19, 2000. Firm-initiated recall ongoing. DISTRIBUTION Indiana, California, Pennsylvania, Texas, New Jersey. QUANTITY 9 affected devices contain 41 restrictors. REASON Metal shavings were found in Steris Quick Connect Kits used with endoscopic device. _______ PRODUCT Dialysis Reverse Osmosis Water System, single unit/stand alone water treatment system used in hemodialysis applications, designed to pre-treat and purify potable water for use in making dialysate for hemodialysis: a) Model MROS; b) Model MRO1; c) MRO2. Recall #Z-875/877-0. CODE Serial Numbers: 97002 to 97038. MANUFACTURER Ameriwater, Dayton, Ohio. RECALLED BY Manufacturer, by product bulletin on March 24, 1998. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide, British Virgin Islands. QUANTITY 35 devices were distributed. REASON Device fails to meet specifications prior to distribution.END OF ENFORCEMENT REPORT FOR JULY 26, 2000. ####
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