August 23, 2000 00-34RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Baron Peanut Butter in 18-ounce plastic jars. Recall #F-780-0. CODE None. MANUFACTURER Bajaj Foods, Ltd., Ahmedabad, India. RECALLED BY United Trading, Williamsville, New York, by fax on July 6, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Agriculture & Markets. DISTRIBUTION New York. QUANTITY 25 cases (12 units per case) were distributed. REASON The product contains 58 ppb of aflatoxin.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
__________ PRODUCT Serafin brand Vanilla Dominicana in 2-ounce and 4-ounce rigid plastic bottles, 24 bottles per case. Recall #F-781-0. CODE None. MANUFACTURER Natrex Manufacturing Company, Brooklyn, New York. RECALLED BY Manufacturer, by telephone on December 16, 1999. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 51 cases of the 2 ounce bottles and 52 cases of the 4-ounce bottles were distributed. REASON Product is not labeled as imitation vanilla. It contains ethyl vanillin, which is not an ingredient in standardized vanilla products.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT a) Standardized Kentucky (June) Bluegrass Pollen Extract b) Standardized 3 Grass Pollen Mix c) Standardized 6 Grass Pollen Mix d) NWU Standardized Grass Mix e) Individual Patient Treatment Vials - Drops f) Individual Patient Treatment Vials - Injectable. Recall #B-929/934-0. CODE Standardized Kentucky (June) Bluegrass Pollen Extract, 10,000 BAU/ml, Lot D512082B Standardized 3 Grass Pollen Mix Lot D8010509 Standardized 6 Grass Pollen Mix Lot D8010508 NWU Standardized Grass Mix Lot D8012801 Individual Patient Treatment Vials - First lot number listed -16470106 Individual Patient Treatment Vials - 15 or 30 ml of sterile injectable vials - First lot number listed - 16475007. For a complete list of lot numbers, contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220. MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, Ohio. RECALLED BY Manufacturer, by telephone on June 25, 1998, and by letters on July 8, 1998, and August 27, 1998. Firm-initiated recall complete. DISTRIBUTION Illinois, Maryland, Minnesota, Indiana, Ohio, New York, West Virginia, Arizona. QUANTITY a) 5/5ml vials, 8/10 ml vials, 1/30 ml vial, 5/50 ml vials b) 1/50 ml vial; c) 1/20 ml vial; d) 3 vials; e) 46 vials of 15 or 30 ml vials of oral drops; f) 34 vials were distributed. REASON Allergenic extracts may have been contaminated with Penicillium sp. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-995/997-0. CODE Unit numbers: a) 19GN41477, 19GN41478, 19GN41480, 19GN41490, 19GN41493,19GN41550, 19GN41551, 19GN41552, 19GN41558,19GN41563,19GN41583; b) 19GN41477, 19GN41478 c) 19GN41477, 19GN41493, 19GN41550, 19GN41551, 19GN41552, 19GN41558, 19GN41563, 19GN41583. MANUFACTURER American Red Cross Blood Services, Paducah, Kentucky. RECALLED BY American Red Cross Blood Services, Nashville, Tennessee, by telephone on November 4, 1998, followed by letter dated November 17, 1998. Firm- initiated recall complete. DISTRIBUTION Kentucky, Tennessee, Californa. QUANTITY a) 11 units; b) 2 units; c) 8 units were distributed. REASON Blood products were collected in a manner that may have compromised the sterility of the units. ________ PRODUCT Platelets. Recall #B-1011-0. CODE Unit #1672794. MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, Kentucky. RECALLED BY Manufacturer, by letter dated July 17, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Platelets were prepared from a unit collected from a donor who had taken aspirin within three days of donation. ________ PRODUCT Platelets. Recall #B-1023-0. CODE Unit #24KW26445. MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated June 5, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Platelets were prepared from a unit collected from a donor who was taking Feldene. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1024/1025-0. CODE Unit #42FR79545. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated April 24, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the drug Arava. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-1027-0. CODE Unit #H81499. MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois. RECALLED BY Manufacturer, by letter dated April 25, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Patellar Tendon - Hemi, Model No. T030, Serial Numbers 4092163, 4092155 , 4092228, 4092201, 4100344, 4100336, 4100328, 4161335, 4161343, 4161351, 4161378 Saphenous Vein, Model No. V010, Serial Numbers 3917983, 6297862, 6297897, 6287972, 6287999 Achilles Tendon, Model No. T010, Serial Numbers 4100379, 4161386, 4161394, 4142659 Pulmonary Trunk Patch, Model No. P010, Serial Numbers 3999319, 6008879 ALT Pulmonary Artery, Model No. A035 Serial Number 6276385 Ascending Thoracic Aorta, Model No. A010, Serial Numbers 6100589, 6056547 Quadriceps Tendon, Model No. T050, Serial #4121139 Semiendinosus Tendon, Model No. T060, Serial #4121112 Saphenous Vein, Model No. V010, Serial #6210848 Pericardium, Model No. PM00, Serial Numbers 3887715, 3889114 Lateral Meniscus - Bone -Right, Model No. M020, Serial Numbers 4062205, 4161297, 4142624 Medial Meniscus - Bone -Right, Model No. M010, Serial Numbers 4161289, 4142616 Medial Meniscus - Bone - Left, Model No. M030 Serial Numbers 4161319, 4142675 Lateral Meniscus - Bone - Left, Model No. M040, Serial Numbers 4161327, 4142683 Patellar Tendon, Model No. T020, Serial Numbers 4142691, 4142632 Pulmonary Branch Patch, Model No. P020, Serial #6298168 Pulmonary Hemi-Artery, Model No. PH00, Serial #6297854. Recall #B-1028-0. CODE See above. MANUFACTURER CryoLife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letters dated March 3, 6, 9, 10, 23, 27, 2000, April 6, 7, 10 or 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Arizona, California, Colorado, Florida, Illinois, Kansas, Kentucky, Massachusetts, Minnesota, Nevada, New Jersey, Virginia, Wisconsin, Canada, Korea. QUANTITY 43 units were distributed. REASON Various human bone and musculoskeletal tissues for transplant, which were collected from donors who had not been properly evaluated. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1029/1031-0. CODE Unit #8504156. MANUFACTURR Community Blood center, Dayton, Ohio. RECALLED BY Manufacturer, by letter dated April 4, 2000, and by fax on March 16, 2000, and July 17, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of jaundice. ________ PRODUCT Whole Blood. Recall #B-1035-0. CODE Unit #Y25309. MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois. RECALLED BY Manufacturer, by telephone on May 2, 2000. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Autologous whole blood unit tested repeatedly reactive for Anti-HBc was not labeled with "biohazard" label. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets; d) Cryoprecipitated AHF; e) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-1036/1041-0. CODE Unit Numbers: a) 0427406, 9983270; b) 9940305; c) 0427406, 9940305, and pooled unit 66876 d) 66870 (pooled unit); e) 0427406, 9940305; f) 9983270. MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated December 2, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio, Kentucky, Florida. QUANTITY a) 2 units; b) 1 unit; c) 2 units and 1 pooled unit; c) 1 pooled unit; d) 1 pooled unit; e) 2 units; f) 1 unit distributed. REASON Blood products were collected from a donor whose spouse tested positive for Hepatitis B. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Platelets; d) Recovered Plasma. Recall #B-1042/1045-0. CODE Unit numbers: a) 42R45027, 42R42872, 42J14585; b) 42R45027, 42J14585; c) 42R45027; d) 42R42872. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated May 15, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio and California. QUANTITY a) 3 units; b) 2 units; c) 1 unit; d) 1 unit distributed. REASON Blood products were collected from a donor with a history of having tested positive for Hepatitis A. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1046/1048-0. CODE Unit Numbers: a) 33KM60726, 33KG72300, 33KE03595, 33KK88749, 33KJ80302, 33KL79920, 33KY21491 b) 33KG72300, 33KK88749, 33KJ80302, 33KL79920, 33KY21491, 33LM29901; c) 33KM60726, 33KG72300, 33KE03595, 33KK88749, 33KJ80302, 33KL79920, 33KY21491, 33LM29901. MANUFACTURER American Red Cross Blood Services, Farmington, Connecticut. RECALLED BY Manufacturer, by letter dated February 9, 2000. Firm-initiated recall complete. DISTRIBUTION Alabama, Connecticut, North Carolina, California. QUANTITY a) 7 units; b) 6 units; c) 8 units were distributed. REASON Blood products tested negative for HbsAg and anti-HBc, but were collected from donors whose previous confirmatory test results were reclassified as HbsAg positive. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-1049-0. CODE Unit #15009-7288. MANUFACTURER United Blood Services, Inc., Texas Blood Institute-Lubbock Center, Lubbock, Texas. RECALLED BY Manufacturer, by telephone on February 13, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was distributed after receiving information from the donor concerning a post donation illness. ________ UPDATE Red Blood Cells, Recall #B-980-0, (BSI Meridian, Mississippi), which appeared in the August 16, 2000, Enforcement Report should read Unit #16341-4733.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT a) Allergenic Extract 5 Mold Mix, 5 ml, Testing-Scratch-Prick; b) Allergenic Extract 5 Mold Mix, 5 ml, Injectable; c) Allergenic Extract 5 Mold Mix, 5 ml, Oral Drops. Recall #B-1020/1022-0. CODE Lot Numbers: a) B9006659, B9007298, B9007499, B9007510, B0008829, B0008976, B0009261, B0009941 b) 16906510, 16907910, 16908425, 16929203, 16935407, 16935606, 16936018, 16931701, 16937418, 16929001, 16933601, 16933701, 16934901, 16939203, 16939602, 16941601, 16942601, 16945004, 16946202, 16946401, 16946901, 16947501, 16947901, 16952112, 16948111, 16948712, 16945202, 16945403, 16953810, 16933201, 16956416, 16956502, 16957209, 16957701, 16958914, 16959503, 16956608, 16957505, 16957605, 16967003, 16962807, 16963204, 16967401, 16964615, 16966803, 16968207, 16969805, 16970902, 16971402, 16971702, 16971802, 16971902, 16971102, 16968309, 16968905, 16969303, 16969605, 16904314, 16972711, 16973108, 16973411, 16973713, 16974107, 16977006, 16977604, 16978002, 16979501, 16977109, 16977404, 16982641, 16982704, 16983003, 16978102, 16978302, 16978402, 16978801, 16978901, 16979601, 16983801, 16976802, 16979301, 16983101, 16985014, 16985231, 16987402, 16988908, 16989111, 16989409, 16988001, 16988101, 16985125, 16985613, 16991704, 16992102, 16992801, 16988201, 16988301, 16994204, 16994305, 16994902, 16995801, 16996101, 16996317, 16996506, 16985708, 16991504, 16986218, 16993106, 16991804, 16986804, 16986904, 16992202, 16988610, 16989013, 16993010, 16989311, 16989604, 16998126, 16986304, 16999205, 16999304, 16998603, 16982502, 16999604, 16987502, 16987702, 16995601, 17001722, 17002136, 17000502, 17000901, 17001101, 17001520, 17001806, 17001903, 17001610, 17007525, 17005108, 17007604, 16999802, 17005803, 17006003, 17000302, 17006720, 16998405, 17005303, 17006202, 17007909, 16998303, 17001201, 17002304, 17005202 c) 17002428, 16974429, 16980028, 17002525, 17002627, 16952227, 16974564, 16980206, 16993207, 17008110, 16974709, 16980310, 16989807, 17002708, 16949209, 16989930, 16915806, 16984206, 17002806, 16967503, 16926525, 16952505, 16975149, 16943104, 16990103, 17003102, 16926901, 16927101, 16927201, 16927701, 17003304, 17003402, 16981021, 17003562, 16984324, 16975420, 16975545, 16990502, 16950201, 17008403, 16966002, 16976903, 17008603, 16966101, 16984401, 16997102, 16984601, 16984801, 16990701, 16984923, 16990801, 16993601, 16997201, 17003701, 17008901, 17009301, 16966325, 16982013, 16991119, 16938617, 16917416, 16917508, 17009849, 16938747, 16993856, 17004217, 16966715, 16976117, 16976706, 16993914, 16976313, 16915102, 16960704, 17010006, 16915210, MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, Ohio. RECALLED BY Manufacturer, by telephone on July 12, 2000, and by letters mailed beginning July 13, 2000. Firm-initiated recall complete. DISTRIBUTION Connecticut, Kentucky, Maryland, Ohio, California, Pennsylvania, Illinois. QUANTITY a) 17 vials; b) 152 individual patient treatment vials c) 75 individual patient treatment vials were distributed. REASON Allergenic extracts were labeled with extended expiration dates. ________ PRODUCT Recovered Plasma. Recall #B-1026-0. CODE Unit #42FR79545. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by fax on May 5, 2000. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor taking the drug Arava.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Laser Pointers, wide range in academic, industry and consumer use: a) Model DPGL; b) Model DPIR Recall #Z-881/882-0. CODE a) DPGL Series 1000, 2000, 3000, 3000F; b) DPIR Series 1000 and 2000, and Polaris Laser Pointer. MANUFACTURER Casix, Inc., Chatsworth, California. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on August 7, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 1,280 units were distributed. REASON Noncompliance with performance with the Federal laser product performance standard, 21 CFR 1040.10 in that products lack beam attenuators, emission indicators, remote interlock connectors, and required labeling. ________ PRODUCT Diode-pumped solid state micro lasers, for various uses including academia and industry applications. Recall #Z-883/885-0. CODE Model Numbers 43XX, 45XX, 46XX. MANUFACTURER JDS Uniphase, Manteca, California. RECALLED BY Manufacturer. FDA approved the firmís corrective action plan on August 7, 2000. Firm initiated fielda correction ongoing. DISTRIBUTION Nationwide. QUANTITY 40 units were distributed. REASON The laser product failed to comply with the Federal laser product performance standard, 21 CFR 1040.10 in that the following deficiencies: beam attenuator, key control, emission indicator, remote interlock connector and labeling. ________ PRODUCT a) Baxter Thermo(tm) Stat Hypothermia Warming Mitt/Seal (Hand Model), Catalogue No. 10-1005/1T0310; b) Aquarius Medical Corporation Thermal Rescue Hypothermia Warming Mitt and Seal (Hand Model), Catalog No. 06-0003/1T0311; c) Aquarius Medical Corporation Thermal Rescue Hypothermia Warming Mitt and Seal (Hand Model), Catalogue No. TR-04004/ETR-04004. Recall #Z-891/893-0. CODE All lot numbers. MANUFACTURER Aquarius Medical Corporation, Scottsdale, Arizona. RECALLED BY Manufacturer, by letter on April 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alaska, Arizona, California, Colorado, Georgia, Illinois, Massachusetts, Maryland, Michigan, Missouri, Montana, New York, Oregon, Pennsylvania, Texas, District of Columbia, Canada, Norway. QUANTITY Approximately 2,440 units were distributed. REASON Water evaporates through the polyvinyl chloride bag over extended periods of storage, leading to a higher salt concentration with increase in mitt temperature, with possible thermal injury to the patient. ________ PRODUCT Bear 1000 Ventilator, an adult/pediatric ventilator intended to provide continuous mechanical ventilation of adult and pediatric patients: a) Catalog #50-08550; b) 50-08555; c) 50-08560; d) 50-08570. Recall #Z-894/897-0. CODE Various serial numbers in the range 11008756 to 11008959, shipped from 1/17/00 to 4/28/00. MANUFACTURER Bear Medical Systems, Palm Spring, California. RECALLED BY Manufacturer, by letter dated June 2, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Alabama, California, Florida, Louisiana, Massachusetts, Missouri, New York, Pennsylvania, Texas, Washington state, West Virginia, Algeria, Brazil, Canada, China, Costa Rica, Greece, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Korea, Mexico, The Netherlands, Russia, Saudi Arabia, Turkey, The United Arab Emirates. QUANTITY 185 ventilators are in distribution. In addition 24 EPI circuit board service replacements were distributed. REASON There is possible corrosion of the mechanical relay that activates the loss of power alarm. ________ PRODUCT Fukuda Denshi, Model DS-5300 Patient Monitor, used to monitor one or more of the following on an individual patient: ECG, respiration, non-invasive and/or invasive blood pressures, temperature, pulse oximetry and cardiac output. Recall Z-898-0. CODE Serial number range: 27120281 through 29061471 (non-consecutive). MANUFACTURER Fukuda Denshi Company, Ltd., Tokyo, Japan. RECALLED BY Fukuda Denshi USA, Inc., Redmond, Washington, by letter on July 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Florida, Pennsylvania, California, Arizona, Ohio, New Hampshire, Kentucky, and Canada. QUANTITY 96 units were distributed. REASON Power supply sub-assembly may fail causing the DS 5300 Patient Monitor to become inoperable. ________ PRODUCT Trilogy Acetabular System Longevity Crosslinked Polyethylene Liner, intended for cemented or non-cemented use in adults undergoing primary surgery for rehabilitating hips: a) Zimmer Trilogy Acetabular System Longevity Crosslinked Polyethylene Liner, Standard, 28 mm I.D., for use with 60 mm O.D. Shell, Catalog No. 00-6305-060-28; b) Zimmer Trilogy Acetabular System Longevity Crosslinked Polyethylene Liner, 7mm Ofset, 32 mm I.D., for use with 70 mm O.D. Shell, Catalog No. 00-6341-070-3. Recall #Z-900/901-0. CODE a) Lot No. 67465500; b) Lot No. 67257700. MANUFACTURER Zimmer, Inc., Warsaw, Indiana. RECALLED BY Manufacturer, by letter on July 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Illinois, Kansas, Louisiana, Maryland, Massachusetts, Minnesota, Nebraska, Oregon, Pennsylvania, Texas, Virginia, Washington state, Wisconsin, Australia. QUANTITY 27 units were distributed. REASON 70 mm liners are inside a 60 mm package.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Merifluor VZV IgM IFA/IFT, a rapid imunofluorescence test kit for the detection of IgM antibodies to varicella-zoster virus (VZV) in human serum. Recall #Z-902-0. CODE Lot #VZ150.001, Catalog #VZ150/4878031. MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated May 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION Florida, Illinois, Nevada, New York, Oklahoma. QUANTITY 38 units were distributed. REASON The VZV IgM IFA/IFT test kits are incorrectly labeled as EBV IgM IFA/IFT kits. ________ PRODUCT Cephalothin Susceptibility Test Disks, KF 30. Recall #Z-903-0. CODE Catalog #33860, Lot #226063 EXP 11/02. MANUFACTURER Oxoid Ltd., United Kingdom. RECALLED BY Remel, Inc., Lenexa, Kansas, by letter June 27, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 99/5/50 disk cartridge boxes were distributed. REASON Product was labeled as Cephalothin Susceptibility Test Disks but contained Vancomycin Susceptibility Test Disks. ________ PRODUCT Richard Allan Dispos-a-Ture Needles, Eyed Surgical Needles, Mayo Catgut 1/2 Circle Taper Point (Heavy), a disposable suturing needle. Recall #Z- 904-0. CODE Product #216705, Lot #2004-08-06. RECALLED BY Aspen Surgical Products, Inc., Grand Rapids, Michigan, by telephone between October 21-28, 1999, followed by fax. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 60 boxes (72 pounces/2 needles per pouch) were distributed. REASON The outer boxes are labeled to contain, and do contain, product #216705, the individual pouches within the boxes are labeled as product 216706. The two needles are different sizes. ________ PRODUCT Architect i 2000 System. Recall #Z-906-0. CODE All units, all software versions. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois, by letter on April 25, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide, Puerto Rico, Korea, Mexico, Canada, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, Malaysia, Australia, New Zealand. QUANTITY 603 units were distributed. REASON System allows running of samples while the automatic flushing/cleaning occurs.END OF ENFORCEMENT REPORT FOR AUGUST 23, 2000.
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