March 29, 2000 00-13RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______ PRODUCT Cold Smoked Fish Products: Sea Bass (Captain); Trout; Steelhead (Siomga); Shad; Turbot; Assortment (Siomga, Captain, Trout); Assortment (Captain, Salmon); Sturgeon; Salmon; Whitefish; Sable; Mackeral; Herring; Shad in Oil; Siomga in Oil; Assortment (Siomga, Turbot); Assortment (Siomga, Sable, Shad, Turbot); Assortment (Siomga, Sable, Shad). Recall #F-205/222-0. CODE All product on the market at the time of recall initiation. MANUFACTURER Royal Baltic, Ltd., Brooklyn, New York. RECALLED BY Manufacturer, by letter March 13, 2000. FDA Requested recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY Undetermined. REASON Products may be contaminated with Listeria monocytogenes.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Northern brand Kippered Fish products: a) Kippered Fish (Halibut, Salmon, Black Cod), packed 4/10lb/case b) Kippered Salmon Snacks, packed 4/5 lb./case c) Kippered Salmon Tips, packed 4/10 lb./case d) Kippered Salmon Chunklets, packed 4/5 lb./case e) Kippered Salmon, packed 4/5 lb./case f) Kippered Halibut, packed 4/5 lb./case. Recall #F-199/204-0. CODE H029_, H039_, H059_, H099_, H109_, H119_, H139_, H169_, H189_, H209_, H219_, H239_, H249_, H259_, H269_, H279_, H309_, H319_, I019_, I029_, I039_, I069_, I089_, I099_, I109_, I139_, I149_, I159_, I169_, I179_, I209_, I229_, I239_, I249_, I279_, I289_, I299_, I309_, J019_, J049_, J059_, J069_, J089_, J109_, J119_, J129_, J139_, J159_, J189_, J199_, J209_, J219_, J229_, J259_, J269_, J279_, J289_, J299_, K019_, K029_, K039_, K049_, K059_, K089_, K099_, K109_, K119_, K129_, K159_, K169_, K179_, K189_, K199_, K229_, K249_, K299_, K309_, L019_, L029_, L039_, L069_, L079_, L089_, L099_, L109_, L139_, L149_, L159_, L169_, L179_, L229_, L219_, L209_, L239_, L279_, L299_, L309_, A030_, A050_, A060_, A100_, A110_, A130_, A140_, A170_, A200_, A240_, A270_, A280_, A310_, B030_, B040_, B070_, B090_, B100_, B110_, B140_, B150_, B160_. MANUFACTURER Northern Fish Products, Inc., Tacoma, Washington. RECALLED BY Manufacturer, by telephone February 16-18, 2000, and by letter dated February 18, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state, Oregon, California. QUANTITY 12,186 pounds were distributed. REASON Products contain undeclared FD&C Yellow No. 6 and FD&C Red No. 3.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Tuong Ot Sriracha Hot Chili Sauce, in 28-ounce plastic bottles. Recall #F-196-0. CODE All code numbers produced between March and July 1999. Recalled product identification - Look at the FOURTH position of the code and if it is "M", "A", "W", "X", or "Y", it is being recalled. MANUFACTURER Huy Fong Foods, Inc., Rosemead, California. RECALLED BY Manufacturer, by letter on September 13, 1999, or by fax on September 14, 1999. Firm-initiated recall complete. DISTRIBUTION Arkansas, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Massachusetts, Michigan, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, Texas, Washington state, Canada. QUANTITY Approximately 42,300 cases (12 bottles/case) were distributed. REASON The product is unfit for food. Some bottles of product were swollen and the product appeared fermented. ________ PRODUCT Onion flavored ring snacks in 3/4, 3-1/4, and 5-ounce plastic bags: a) Onion Flavored Rings, under the following labels: Weis Quality, Keystone, Terell's, Trophy, Kitov, and DeMoulas; b) Onion Garlic Flavored Rings, under the Matamin label. Recall #F-197/198-0. CODE All expiration date codes (based on product's 90-day shelf life) with "DEC" through "MAR" appearing on the front side of bag. MANUFACTURER Keystone Food Products, Inc., Easton, Pennsylvania. RECALLED BY Manufacturer, by letter dated December 15, 1999, followed by telephone and visit. Firm-initiated recall ongoing. DISTRIBUTION Connecticut, Kentucky, Massachusetts, Maryland, Maine, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, West Virginia, Canada. QUANTITY 12,969 cases were distributed. REASON Products are unfit for food due to rancidity.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-515/517-0. CODE Unit Numbers: a) 24LE65617, 24LY13367; b) 24LE65617; c) 24LE65617, 24LY13367. MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky. RECALLED BY Manufacturer, by letters dated December 8, 1999, and January 7, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky, Indiana, California. QUANTITY a) 2 units; b) 1 unit; c) 2 units were distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma. Recall #B-518/520-0. CODE Unit #21GC68111. MANUFACTURER American Red Cross, Portland, Oregon. RECALLED BY Manufacturer, by letters dated November 16, 1999, and December 23, 1999, or by phone on November 9, 1999. Firm-initiated recall complete. DISTRIBUTION Oregon, California, Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of exposure to hepatitis. ________ PRODUCT Red Blood Cells, Leukocytes Removed. Recall #B-524-0. CODE Unit #LH16695. MANUFACTURER Blood Centers of the Pacific, San Francisco, California. RECALLED BY Manufacturer, by letter dated May 1, 1998. Firm-initiated recall complete. DISTRIBUTION California. 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-526/527-0. CODE Unit Numbers: a) 8503829, 1080968; b) 1080968. MANUFACTURER Community Blood Center, Dayton, Ohio. RECALLED BY Manufacturer, by letters dated October 14, 1999, or November 5, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY a) 2 units; b) 1 unit. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Fenwall Sepacell PLS-10A Leukocyte Reduction Filter for Platelets. Recall #B-497-0. CODE Lot Numbers: A99E13095, A99G22050, A99H11069. MANUFACTURER Baxter S.A., Fenwal Division, Parque Industrial Itabo, Zona Franca Industrial de Haina, San Christobal, Republica Dominica. RECALLED BY Baxter Healthcare Corporation, Fenwal Division, Deerfield, Illinois, by fax dated October 18, 1999, followed by telephone. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 4,284 units were distributed. REASON Filters used for leukocyte reduction of platelets were assembled with the filter inverted. ________ PRODUCT Cryoprecipitated AHF. Recall #B-521-0. CODE Unit #21KJ26375. MANUFACTURER American Red Cross, Portland, Oregon. RECALLED BY Manufacturer, by telephone on November 5, 1999, and letter dated November 16, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood with an extended collection time. ________ PRODUCT Red Blood Cells. Recall #B-522-0. CODE Unit #20FM09995. MANUFACTURER American Red Cross Blood Services, Missoula, Montana. RECALLED BY Manufacturer, by telephone on February 4, 1999. Firm-initiated recall complete. DISTRIBUTION Idaho. QUANTITY 1 unit was distributed. REASON Blood product was stored at unmonitored temperatures. ________ PRODUCT Olympus PK CMV-PA System Control Set. Recall #B-547-0. CODE Lot 2022 EXP 7/00. MANUFACTURER Scimedx Corporation, Denville, New Jersey. RECALLED BY Manufacturer, by letter dated May 4, 1999. Firm-initiated recall complete. DISTRIBUTION Nationwide and Canada. QUANTITY 66 kits were distributed. REASON Reagent test kit controls exhibit false positive results when used with the Olympus PK CMV-PA Test Systems.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Literature for BioSorb FX 2.0/2.4 Bioabsorbable Fixation System. Recall #Z-449-0. CODE Lot #1939. MANUFACTURER Bionx Implants Ltd., Tampere, Finland. RECALLED BY Bionx Implants, Inc., Blue Bell, Pennsylvania. On September 20, 1999, the recalling firm ceased further distribution of literature and any copies remaining in sales representatives' stock were removed and any copies remaining in distributors' stock will be returned. DISTRIBUTION Canada, Australia, Latin America. QUANTITY 2,550 units were distributed. REASON Device is labeled for unintended use. Firm's sales literature misbrands the device for mandibular indications. ________ PRODUCT Implantable Cardiovascular Defibrillators, used to detect ventricular arrhythmias and deliver therapy for the detected arrhythmia. The devices are designed to treat ventricular fibrillation, ventricular tachycardia, and bradycardia: a) GEM II VR Single Chamber Implantable defibrillator, Model No. 7229CX; b) GEM II DR Dual Chamber Implantable Cardiovascular Defibrillator, Model No. 7273. Recall #Z-452/453-0. CODE Serial Numbers: United States Distribution: Model 7229CX: PJJ200000H, PJJ200001H, PJJ200002H, PJJ200021H, PJJ200024H, PJJ200025H,PJJ200026H, PJJ200027H - PJJ200034H, PJJ200035H, PJJ200036H, PJJ200037H, PJJ200039H and PJJ200040H. Model 7273: PJK200004H, PJK200005H, PJK200010H, JK200015H, PJK200071H - PJK200078H, PJK200108H, PJK200110H, JK200115H, PJK200116H, PJK200119H, PJK200121H, PJK200122H, PJK200124H - PJK200126H, PJK200138H, PJK200139H, PJK200141H, PJK200144H, PJK200147H, PJK200152H, PJK200154H - JK200158H, PJK200160H, PJK200161H, PJK200164H, PJK200167H, PJK200169H - PJK200172H, PJK200178H, PJK200190H - PJK200201H, PJK200203H, PJK200206H, PJK200207H, PJK200211H, PJK200212H, PJK200215H, PJK200217H, PJK200218H, PJK200220H, PJK200221H, PJK200224H, PJK200229H, PJK200268H, PJK200272H, PJK200274H, PJK200279H, PJK200283H - PJK200288H, PJK200294H, JK200296H, PJK200298H - PJK200300H, PJK200302H, PJK200303H, JK200307H, PJK200309H, PJK200311H, PJK200312H, PJK200315H, PJK200317H, PJK200319H, PJK200320H, PJK200323H, PJK200324H, PJK200326H - PJK200328H, PJK200335H, PJK200336H, PJK200338H, PJK200339H, PJK200341H, PJK200345H, PJK200348H, PJK200353H, PJK200354H - PJK200356H, PJK200360H, PJK200364H, JK200369H, PJK200371H, PJK200372H, PJK200381H - PJK200384H, JK200389H, PJK200391H, PJK200395H, PJK200398H, PJK200407H, PJK200408H, PJK200412H, PJK200414H, PJK200415H, PJK200421H, PJK200425H, PJK200427H, PJK200429H - PJK200433H, PJK200435H, JK200436H, PJK200438H, PJK200440H, PJK200441H, PJK200443H, PJK200444H, PJK200450H, PJK200451H, PJK200455H, PJK200458H - JK200461H, PJK200466H, PJK200469H - PJK200482H, PJK200484H, PJK200486H - PJK200489H, PJK200491H, PJK200493H - PJK200495H, PJK200497H, PJK200500H, PJK200502H - PJK200504H, JK200506H, PJK200508H, PJK200509H, PJK200512H - PJK200514H, JK200516H, PJK200518H, PJK200519H, PJK200521H, PJK200523H, PJK200524H, PJK200526H - PJK200537H, PJK200540H - PJK200542H, JK200544H - PJK200547H, PJK200549H, PJK200551H, PJK200555H, PJK200556H, PJK200558H, PJK200559H, PJK200565H - JK200568H, PJK200571H, PJK200572H, PJK200574H, PJK200576H, PJK200577H, PJK200580H, PJK200597H - PJK200599H, PJK200602H, JK200603H, PJK200609H, PJK200610H, PJK200616H, PJK200617H, PJK200618H - PJK200623H, PJK200626H, PJK200628H, JK200629H,PJK200630H, PJK200636H, PJK200656H - PJK200659H, PJK200660H - JK200668H, PJK200670H - PJK200678H, PJK200680H, PJK200682H - PJK200684H, PJK200686H, PJK200688H - PJK200700H, PJK200702H, PJK200703H, PJK200705H - PJK200710H PJK200712H, PJK200713H, PJK200715H, PJK200716H, PJK200718H, PJK200721H, PJK200724H, PJK200726H - PJK200728H, PJK200730H, PJK200732H - PJK200735H PJK200738H, PJK200741H, PJK200743H, PJK200745H - PJK200747H, PJK200757H - PJK200765H, PJK200768H - PJK200774H, PJK200776H, PJK200777H, PJK200779H - JK200781H, PJK200783H, PJK200784H, PJK200787H - PJK200789H, PJK200791H -PJK200796H, PJK200805H, PJK200809H - PJK200817H, PJK200819H - PJK200822H, PJK200826H, PJK200832H, PJK200840H - PJK200845H, PJK200847H - PJK200849H, PJK200851H, PJK200852H, PJK200856H, PJK200860H, PJK200861H, PJK200863H - PJK200869H, PJK200871H, PJK200872H, PJK200874H - PJK200880H, PJK200883H, PJK200884H, PJK200886H, PJK200889H, PJK200891H - PJK200897H, PJK200899H, PJK200900H - JK200907H, PJK200911H - PJK200913H, PJK200918H - JK200920H, PJK200923H, PJK200925H, PJK200926H, PJK200928H - JK200932H, PJK200937H, PJK200940H, PJK200942H, PJK200946H, PJK200948H, PJK200950H, PJK200952H, PJK200954H, PJK200956H - JK200958H, PJK200960H, PJK200963H - PJK200972H, PJK200974H - JK200977H, PJK200979H, PJK200981H - PJK200988H, PJK200991H, PJK200992H, PJK200994H - PJK200999H, PJK201001H, JK201002H, PJK201004H, PJK201005H, PJK201009H - PJK201015H, PJK201017H - PJK201019H, PJK201021H, PJK201023H, PJK201025H, PJK201026H, PJK201029H, PJK201030H, PJK201032H - JK201035H, PJK201037H, PJK201039H - PJK201041H, PJK201049H, JK201050H, PJK201052H, PJK201056H - PJK201061H, PJK201064H, JK201066H, PJK201071H - PJK201077H, PJK201080H, PJK201082H, PJK201084H - PJK201089H, PJK201091H, PJK201103H, PJK201106H, PJK201108H, PJK201117H - PJK201119H, PJK201121H, JK201122H, PJK201124H - PJK201128H, PJK201130H - PJK201132H, PJK201134H, PJK201135H, PJK201136H, PJK201142H - PJK201144H, PJK201146H, PJK201147H - PJK201149H, PJK201158H, PJK201161H, PJK201162H, PJK201165H, PJK201167H, PJK201168H, PJK201170H, PJK201174H, PJK201177H, PJK201180H, PJK201182H, PJK201183H, PJK201184H, PJK201185H, PJK201187H, PJK201189H - PJK201191H, PJK201194H - PJK201199H, PJK201202H, PJK201204H, PJK201205H, PJK201207H, PJK201208H, PJK201209H, PJK201211H, PJK201212H, PJK201213H, PJK201214H, PJK201215H, PJK201216H, PJK201217H, PJK201218H, PJK201219H, PJK201222H - PJK201224H, PJK201247H, PJK201248H - PJK201252H, PJK201254H, PJK201255H, PJK201259H, PJK201260H, PJK201262H - PJK201265H, PJK201268H, PJK201269H, PJK201272H - PJK201274H, PJK201277H - PJK201284H, PJK201289H - PJK201299H, PJK201301H - PJK201303H, PJK201305H, PJK201307H, PJK201310H, PJK201312H, PJK201314H, PJK201316H, PJK201317H, PJK201320H, PJK201322H - PJK201325H, PJK201329H - PJK201331H, PJK201333H, PJK201334H, PJK201336H, PJK201338H - PJK201343H, PJK201345H, PJK201346H, PJK201350H - PJK201355H, PJK201357H, PJK201360H - PJK201363H, PJK201365H, PJK201367H - PJK201370H, PJK201372H - JK201375H, PJK201378H - PJK201380H, PJK201382H, PJK201384H, PJK201386H, PJK201387H, PJK201389H - PJK201391H, JK201394H, PJK201395H, PJK201398H - PJK201400H, PJK201408H, JK201409H, PJK201411H, PJK201413H, PJK201414H, PJK201416H, PJK201419H, PJK201420H, PJK201422H, PJK201423H, PJK201425H, PJK201426H, PJK201428H - PJK201431H, PJK201434H, PJK201435H, PJK201437H, PJK201438H, PJK201443H - PJK201445H, PJK201448H - PJK201450H, PJK201452H, PJK201453H, PJK201454H, PJK201456H, PJK201458H, PJK201459H, PJK201463H - PJK201469H, PJK201472H, PJK201474H, PJK201475H, PJK201480H, PJK201481H, PJK201494H, PJK201498H, PJK201499H, PJK201504H - PJK201506H, PJK201507H - PJK201510H, PJK201512H, PJK201513H, PJK201515H, PJK201517H, PJK201518H, PJK201521H - PJK201523H, PJK201525H - PJK201530H, PJK201534H, PJK201535H, PJK201537H - PJK201542H, PJK201544H - JK201549H, PJK201551H - PJK201554H, PJK201557H, PJK201559H, PJK201595H, PJK201597H, PJK201601H, PJK201604H - PJK201607H, PJK201609H - PJK201614H, PJK201616H, PJK201620H, PJK201630H - PJK201639H, PJK201641H, PJK201642H, PJK201647H, PJK201648H, PJK201676H, PJK201677H, PJK201679H, PJK201680H, PJK201700H, PJK201702H - PJK201704H, PJK201710H - PJK201714H, PJK201720H, PJK201722H - PJK201725H, PJK201727H - PJK201729H, PJK201731H, PJK201734H - PJK201736H, PJK201739H - PJK201742H, PJK201744H, PJK201745H, PJK201747H - PJK201755H, PJK201757H - PJK201761H, PJK201763H, PJK201764H, PJK201769H, PJK201770H, PJK201772H, PJK201774H, PJK201778H - PJK201780H, PJK201782H - PJK201789H, PJK201791H - PJK201793H, PJK201796H - PJK201800H, PJK201802H, PJK201809H, PJK201812H, PJK201813H, PJK201817H, PJK201818H, PJK201822H, PJK201823H, PJK201828H, PJK201829H, PJK201836H, PJK201839H, PJK201843H, PJK201844H, PJK201849H - PJK201851H, PJK201853H - PJK201858H, PJK201861H, PJK201864H - PJK201866H, PJK201869H - PJK201875H, PJK201877H, PJK201878H, PJK201880H - PJK201882H, PJK201889H, PJK201891H, PJK201892H, PJK201894H - PJK201897H, PJK201900H, PJK201901H, PJK201903H - PJK201906H, PJK201908H, PJK201910H, PJK201911H, PJK201914H, PJK201915H, PJK201917H, PJK201919H, PJK201921H, PJK201923H - PJK201926H, PJK201929H, PJK201930H, PJK201932H, PJK201933H - PJK201942H, PJK201945H, PJK201946H, PJK201948H, PJK201949H, PJK201951H, PJK201956H, PJK201960H, PJK201962H, PJK201964H, PJK201965H, PJK202079H - PJK202081H, PJK202164H - PJK202167H, PJK202169H, PJK202171H, PJK202172H, PJK202176H, PJK202177H, PJK202179H, PJK202181H, PJK202182H, PJK202186H, PJK202187H, PJK202189H - PJK202193H, PJK202195H - PJK202197H, PJK202199H, PJK202202H, PJK202203H - PJK202205H, PJK202208H, PJK200490H, PJK200604H, PJK200615H, PJK200687H, PJK200890H, PJK200980H, PJK201022H, PJK201053H, PJK201166H, PJK201246H, PJK201315H, PJK201366H, PJK201516H, PJK201628H, PJK201718H, PJK201762H, PJK201773H, PJK201920H, PJK202194H, PJK202754H, PJK203409H, PJK207051H, PJK207054H, PJK207056H - PJK207059H, PJK207063H, PJK200112H, PJK200118H, PJK200123H, PJK200153H, PJK200209H, PJK200280H, PJK200306H, PJK200410H, PJK200445H, PJK200485H, PJK200492H, PJK200501H, PJK200515H, PJK200520H, PJK200548H, PJK200612H, PJK200701H, PJK200711H, PJK200722H, PJK200725H, PJK200736H, PJK200753H, PJK200755H, PJK200782H, PJK200790H, PJK200888H, PJK200908H, PJK200910H, PJK200914H, PJK200915H, PJK200917H, PJK200922H, PJK200951H, PJK200959H, PJK200973H, PJK200978H, PJK201000H, PJK201024H, PJK201038H, PJK201044H, PJK201047H, PJK201094H, PJK201120H, PJK201129H, PJK201141H, PJK201159H, PJK201169H, PJK201173H, PJK201176H, PJK201186H, PJK201188H, PJK201193H, PJK201203H, PJK201206H, PJK201210H, PJK201221H, PJK201261H, PJK201287H, PJK201288H, PJK201337H, PJK201347H, PJK201349H, PJK201364H, PJK201376H, PJK201383H, PJK201388H, PJK201412H, PJK201415H, PJK201418H, PJK201421H, PJK201432H, PJK201433H, PJK201436H, PJK201441H, PJK201447H, PJK201455H, PJK201457H, PJK201462H, PJK201479H, PJK201490H, PJK201502H, PJK201511H, PJK201514H, PJK201519H, PJK201533H, PJK201536H, PJK201555H, PJK201558H, PJK201596H, PJK201603H, PJK201615H, PJK201654H, PJK201707H, PJK201719H, PJK201721H, PJK201733H, PJK201737H, PJK201756H, PJK201768H, PJK201790H, PJK201814H, PJK201848H, PJK201863H, PJK201868H, PJK201885H, PJK201898H, PJK201899H, PJK201902H, PJK201931H, PJK201963H, PJK202168H, PJK202175H, PJK202201H, PJK207050H and PJK207055H. Distribution to Australia: Model 7273: PJK200319S, PJK200320S, PJK200738S, PJK200740S, PJK201842H, PJK201909H, PJK201912H, PJK201916H, PJK201927H, PJK200399S, PJK200412S, and PJK200419S. Distribution to Canada: Model 7273: PJK200174H, PJK200214H, PJK200305S, PJK200310S, PJK200322S, PJK200323S, PJK200346S, PJK200520S, PJK200521S, PJK200522S, PJK200524S, PJK200526S, PJK200528S, PJK200606H, PJK200607H, PJK200611H, PJK200696S, PJK200743S, PJK200762S, PJK200768S, PJK200853H, PJK200857H, PJK200989H, PJK201815H, PJK201834H, PJK201835H, PJK201837H, PJK201838H, PJK201883H, PJK201922H, PJK202178H, PJK202209H, PJK200415S and PJK200424S. Distribution to Europe: Model 7229Cx: PJJ200038S, PJJ200040S, PJJ200045S, PJJ200077R, PJJ200078R, PJJ200079R, PJJ200080R, PJJ200082R - PJJ200088R, PJJ200090R - PJJ200092R, PJJ200094R - PJJ200098R, PJJ200100R - PJJ200104R, PJJ200106R, PJJ200107R, PJJ200109R, PJJ200110R - PJJ200116R, PJJ200118R - PJJ200120R, PJJ200124R - PJJ200126R, PJJ200128R - PJJ200133R, PJJ200135R - PJJ200138R, PJJ200162R, PJJ200164R - PJJ200166R, PJJ200168R, PJJ200170R - PJJ200172R, Model 7273: PJK100462R, PJK100467R, PJK100471R, PJK100476R - PJK100478R, PJK100545R - PJK100552R, PJK100554R, PJK100556R - PJK100558R, PJK100592R, PJK100593R, JK100595R, PJK100600R - PJK100603R, PJK100606R - PJK100608R, JK100612R - PJK100619R, PJK100625R - PJK100629R, PJK100632R, PJK100636R, PJK100640R, PJK100642R, PJK100643R, PJK100646R, PJK100651R - PJK100653R, PJK100656R, PJK100657R, PJK100661R, PJK100663R - PJK100665R, PJK100669R, PJK100670R, PJK100672R, PJK100675R, PJK100677R - PJK100679R, PJK100681R, PJK100682R, PJK100684R, PJK100685R, PJK100687R - PJK100694R, PJK100718R - PJK100726R, PJK100729R - PJK100735R, PJK100737R, PJK200022R, PJK200023R, PJK200029R, PJK200031R, PJK200032R, PJK200036R - PJK200038R, PJK200040R, PJK200064S, PJK200066S, PJK200067S - PJK200070S, PJK200108S, PJK200109S, PJK200115S, PJK200124S, PJK200126S, PJK200131S - PJK200134S, PJK200136S, PJK200173H, PJK200175H, PJK200204H, PJK200242S, PJK200254S, PJK200266H, PJK200267H, PJK200285S, PJK200287S - PJK200291S, PJK200293S, PJK200294S, PJK200296S, PJK200298S, PJK200300S, PJK200302S, PJK200303S, PJK200313S, PJK200317S, PJK200344S, PJK200365S, PJK200367S, PJK200373S - PJK200376S, PJK200378S - PJK200380S, PJK200382S - PJK200388S, PJK200390S - PJK200393S, PJK200395S - PJK200398S, PJK200400S - PJK200404S, PJK200407S, PJK200409S, PJK200411S, PJK200413S, PJK200414S, PJK200416S - PJK200418S, PJK200420S - PJK200422S, PJK200423S, PJK200425S, PJK200427S.PJK200428S, PJK200513S - PJK200515S, PJK200519S, PJK200525H, PJK200529S, PJK200532S, PJK200533S, PJK200538H, PJK200539H, PJK200597S - PJK200600S, PJK200603S - PJK200608S, PJK200610S - PJK200617S, PJK200619S, PJK200620S, PJK200622S, PJK200623S, PJK200624H, PJK200625H, PJK200625S, PJK200627H, PJK200627S, PJK200632S, PJK200634S, PJK200693S, PJK200695S, PJK200697S - PJK200699S, PJK200701S, PJK200702S, PJK200704S, PJK200706S - PJK200709S, PJK200712S, PJK200713S, PJK200715S - PJK200720S, PJK200723S, PJK200725S, PJK200728S - PJK200731S, PJK200731H, PJK200732S, PJK200733S, PJK200735S, PJK200736S, PJK200739H, PJK200739S, PJK200741S, PJK200742H, PJK200742S, PJK200746S, PJK200748H, PJK200748S, PJK200750H - PJK200752H, PJK200756H, PJK200757S, PJK200767S, PJK200772S, PJK200786H, PJK200797H, PJK200799H, PJK200801H, PJK200803H, PJK200804H, PJK200806H, PJK200823H, PJK200824H, PJK200827H - PJK200831H, PJK200833H, PJK200835H - PJK200839H, PJK200881H, PJK200933H, PJK200934H, PJK200936H, PJK200938H, PJK200941H, PJK200943H, PJK200944H, PJK201065H, PJK201070H, PJK201078H, PJK201081H, PJK201138H, PJK201139H, PJK201145H, PJK201150H, PJK201152H, PJK201153H, PJK201154H, PJK201156H, PJK201157H, PJK201160H, PJK201164H, PJK201171H, PJK201175H, PJK201300H, PJK201306H, PJK201309H, PJK201311H, PJK201313H, PJK201319H, PJK201335H, PJK201442H, PJK201470H, PJK201471H, PJK201492H, PJK201493H, PJK201500H, PJK201501H, PJK201503H, PJK201705H, PJK201706H, PJK201738H, PJK201808H, PJK201811H, PJK201816H, PJK201819H, PJK201821H, PJK201824H - PJK201827H, PJK201830H - PJK201833H, PJK201840H, PJK201947H, PJK201950H, PJK201961H, PJK201966H and PJK201968H. Distribution to Hong Kong: Model 7273: PJK200249S, PJK200286S, PJK200679H, PJK200909H, PJK200945H, PJK201473H, PJK201820, PJK202206H, and PJK202207H. MANUFACTURER Medtronic, Inc., Minneapolis, Minnesota; Medtronic Med Rel, Inc., Humacao, Puerto Rico; Medtronic, Switzerland Manufacturing Operations, Tolochenaz, Switzerland. RECALLED BY Medtronic, Inc., Minneapolis, Minnesota, by letter dated February 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,628 defibrillators were distributed from December 1998 to November 1999. REASON A fracture of a soldered connection in the devices could result in loss of telemetry and device output. ________ PRODUCT Various Heart Valves and Annuloplasty Rings: a) St. Jude Medical Masters Series Rotatable Aortic Mechanical Heart Valve with Silzone Coating, Cuff Type, models: Standard Polyester: 19AS-601, 21AS-601, 23AS-601, 25AS-601, 27AS-601, 29AS-601, 31AS-601. Expanded Polyester: 19AECS-602, 21AECS-602, 23AECS-602, 25AECS-602, 27AECS-602, 29AECS-602, 31AECS-602. Hemodynamic Plus Cuff: 17AHPS-605, 19AHPS-605, 21AHPS-605, 23AHPS-605, 25AHPS-605, 27AHPS-605. Expanded HP Cuff: 17AEHPS-605, 19AEHPS-605, 21AEHPS-605, 23AEHPS-605, 25AEHPS-605, 27AEHPS-605. b) St. Jude Medical Masters Series Rotatable Mitral Mechanical Heart Valve with Silzone Coating, Cuff Type, models: Standard Expanded Polyester: 19MS-601, 21MS-601, 23MS-601, 25MS-601, 27MS-601, 29MS-601, 31MS-601, 33MS-601, 35MS-601, 37MS-601. Expanded Polyester: 19MECS-602, 21MECS-602, 23MECS-602, 25MECS-602, 27MECS-602, 29MECS-602, 31MECS-602, 33MECS-602. Hemodynamic Plus: 17MHPS-605, 19MHPS-605, 21MHPS-605, 23MHPS-605 25MHPS-605, 27MHPS-605. Expanded HP Cuff: 17MEHPS-605, 19MEHPS-605, 21MEHPS-605, 23MEHPS-605, 25MEHPS-605, 27MEPHS-605. c) St. Jude Medical Regent Rotatable Aortic Mechanical Heart Valve with Standard Polyester Cuff Having Silzone Coating, models: 17-AG-701, 19-AG- 701, 21-AG-701, 23-AG-701, 25-AG-701, 27-AG-701, 29-AG-701; d) St. Jude Medical Regent Rotatable Aortic Mechanical Heart Valve with Flex/Polyester Cuff Having Silzone Coating, models: 17AGF706, 19AGF706, 21AGF706, 23AGF706, 25AGF706, 27AGF706, 29AGF706; e) St. Jude Medical Seguin Annuloplasty Ring for Mitral Valve Repair with Silzone Coating, models: SARS-M24, SARS-M26, SARS-M28, SARS-M30, SARS- M32, SARS-M34, SARS-M36, SARS-M38, SARS-M40; f) St. Jude Medical Tailor Annuloplasty Ring with Silzone Coating, models: TAR-25, TAR-27, TAR-29, TAR-31, TAR-33, TAR-35; g) St. Jude Medical Epic Porcine Aortic Bioprosthetic Heart Valve, models: ELS-21A, ELS-23A, ELS-25A, ELS-27A, ELS-29A, ELS-31A; h) St. Jude Medical Epic Porcine Mitral Bioprosthetic Heart Valve, models: ELS-21M, ELS-23M, ELS-25M, ELS-27M, ELS-29M, ELS-31M. Recall #Z-454/461-0. CODE All serial numbers of SMJ valves and annulplasty rings with Silizone silver coating. MANUFACTURER St. Jude Medical, Inc., St. Paul, Minnesota. RECALLED BY Manufacturer, by letters on January 21 and 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 47,283 mechanical heart valves, 963 Epic Porcine valves, and 3,083 annuloplasty rings were distributed. REASON There is a statistically significant higher rate of paravalvular leaks with the silver ion (Silzone) coated sewing cuffs leading to valve explants. ________ PRODUCT Alycon Analyzers, automated chemistry analyzers for in-vitro diagnostic use: a) Alycon Analyzer 300; b) Alycon Analyzer 300i. Recall #Z- 462/463-0. CODE All codes. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Manufacturer, by letter dated January 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 535 analyzers distributed in the United States from 5/1/98 to 12/1/99. REASON Software program errors cause incorrect association between patient and the patient results. ________ PRODUCT COBAS Integra Ammonia (NH3L) Cassettes, contains an in-vitro diagnostic reagent intended for use on COBAS Integra 400 and 700 for the quantitative determination of the ammonia concentration in plasma: a) Catalog #0766682; b) Catalog #0737453. Recall #Z-464/465-0. CODE Lot Numbers B2434 EXP 4/00 and B2635 EXP 5/00. MANUFACTURER Roche Diagnostics GmbH, Mannheim, Germany. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter on February9, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON Lithium heparin plasma may give erratic results compared to EDTA plasma using the ammonia assay. ________ PRODUCT Ventak Prism Automatic Implantable Cardioverter Defibrillator, VR Models 1850 and 1855, and DR Models 1851 and 1856. These cardioverter defibrillators are intended for use in patients who are at high risk of sudden cardiac death due to ventricular arrhythmias. Recall #Z-469/470- 0. CODE Model 1850 Serial Numbers: 100027, 100028 - 100030, 100032, 100033, 100036, and 100039. Model 1851 Serial Numbers: 300129 - 300137, 300139 - 300143, 300156 - 300158, 300160 - 300162, 300164 - 300166, 300168 - 300171, 300173 - 300175, 300177, 300178, 300181 - 300190, 300192, 300194, 300195, 300197, 300199, 300201, 300204, 300205, 300207 -300209, 300213, 300216, 300218, 300222, 300224 - 300226, 300228, 300238, 300239, 300243, 300244, 300246 - 300249, 300251, 300252, 300254, 300255, 300261, 300262, 300264, 300266 - 300273, 300277, 300278, 300281, 300283, 300286, 300287, 300290, 300294, 300295, 300298, 300301 - 300306, 300308, 300311 - 300313, 300316, 300321, 300323 - 300326, 300330, 300331, 300336, 300339, 300341, 300343, 300344, 300348 - 300350, 300362, 300363, 300365, 300366, 300376 - 300379, 300381, 300385, 300386, 300388, 300393 - 300399, 300402 - 300405, 300407, 300408, 300410, 300413 - 300416, 300418, 300419, 300421, 300422, 300424, 300425, 300427, 300428, 300429, 300430, 300432, 300437, 300439, 300442, 300448, 300449, 300452 - 300455, 300458, 300460, 300462 - 300469, 300472 - 300478, 300480, 300481, 300484 - 300492, 300494, 300498, 300500 - 300504, 300506 - 300509, 300511, 300512, 300515 - 300517, 300519, 300521, 300525, 300527, 300528, 300533 - 300536, 300542, 300548, 300550, 300551, 300553 - 300555, 300558, 300560, 300562, 300563, 300565 - 300567, 300570 - 300576, 300578 - 300583, 300619 - 300621, 300627, 300628, 300631, 300640, 300643, 300653, 300654, 300656, 300658, 300674, 300676, 300683, 300691, 300695, 300702, 300714, 300719, 300720, 300737, 300738, 300740, 300743, 300744, 300745, 300747, 300748, 300750 - 300752, 300773 - 300775, 300789, 300844, 300845, 300846, 300847, 300852, 300853, 300858, 300862, 300871, 300942, 300963, 301012, 301025, 301204, 301272, 301273, 301274, 301276, 301290, 301339, 301364, 301369, 301376, 301377, 301379, 301381, 301382, 301397, 301406, 301409 - 301411, 301417, 301418, 301420 - 301424, 301426, 301431 - 301433, 301445, 301452, 301454, 301459, 301482 - 301484, 301519, 301544, 301545, 301595, 301608, 301612, 301633, and 301694. Model 1855 Serial Numbers: 500014, 500015, 500016, 500017, and 500018. Model 1856 Serial Numbers: 600027, 600028, 600029, 600030, and 600031. MANUFACTURER Guidant Corporation, St. Paul, Minnesota. RECALLED BY Manufacturer, by memorandum on February 13, 2000, and by letter dated February 14, 2000, followed by visit. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Australia, Canada, Israel, New Zealand, Europe. QUANTITY 364 units. REASON Defect in an integrated circuit that can result in device failure.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Software for Pulmonary Function Testing System: a) BreezePF v3.8 Software, Catalog No. 147536-003; b) BreezePF v3.8A Software, Catalog No. 147570-003. Recall #Z-450/451-0. CODE None. MANUFACTURER Medical Graphics Corporation, St. Paul, Minnesota. RECALLED BY Manufacturer, by bulletin on January 8, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 657 software disks were distributed. REASON An anomaly has been discovered in the software that can cause confusion on the selection of which FEV1/FVC ratio is selected for diagnostic reporting. The problem only occurs when using the Quality Review or Bronchial Provocation Review software to select best composite efforts. ________ PRODUCT VDRL (Venteral Disease Research Laboratory) Test Kit-5.0 mL ampoule, slide test provides both qualitative and semi-quantitative results. Recall #Z-466-0. CODE Part #600902, Lot #VDRLA-107 EXP 10/01. MANUFACTURER Avanti Polar Lipids, Inc., Alabaster, Alabama. RECALLED BY Manufacturer, by verbal communication, followed by letter on February 1, 2000. Firm-initiated recall ongoing. DISTRIBUTION Minnesota. QUANTITY 2 test kits.were distributed. REASON The device was labeled with an incorrect expiration date. ________ PRODUCT Steri-Oss, HL Threaded Implant, HA Coated, endosseous dental implant: Part #5612HL, 5 mm x 12 mm; b) Part #4610HL, 4.5 mm x 10 mm. Recall #Z-467/468-0. CODE Lot Numbers: a) 302453 EXP 10/04; b) 302457 EXP 10/04. MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California. RECALLED BY Manufacturer, by letter on January 19, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Japan, Argentina, South Korea, Hong Kong. QUANTITY a) 144 units; b) 26 units were distributed. REASON Healing screws were mismatched between the two sizes during production assembly.END OF ENFORCEMENT REPORT FOR MARCH 29, 2000. ####
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