Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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January 9, 2008
08-02

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
a) Hot Dog Chili Sauce; 10 oz can; UPC 30300 00101 (Castleberry's Hot Dog Chili
   Sauce), UPC 30300 99533 (Austex Hot Dog Chili Sauce), UPC 11110 83942 (Kroger
    Hot Dog Chili Sauce), UPC 75266 04152 (Bunker Hill Hot Dog Chili Sauce), UPC
    41250 85862 (Meijer Hot Dog Chili Sauce), UPC 35826 06911 (Food Lion Hot Dog
    Chili Sauce), UPC 25439 92448 (Bloom Hot Dog Chili Sauce), and UPC 21140 21367
    (Thrifty Maid Hot Dog Chili Sauce), Recall # F-017-8;
b) Onion Hot Dog Chili Sauce; 10 oz can; UPC 30300 07101 (Castleberry's Onion Hot
    Dog Chili Sauce), UPC 30300 97101 (Austex Onion Hot Dog Chili Sauce),
    Recall # F-018-8
CODE
All the listed canned products with all best by and code dates. The best by date can be found either on the top or bottom of the can.
RECALLING FIRM/MANUFACTURER
Castleberry’s Food Company, Augusta, GA, by press release on July 18, July 21, August 1, 2007 and by telephone, e-mail and letters starting on July 18 and July 22, 2007. Firm initiated recall is ongoing.
REASON
Products may be underprocessed and contain botulinum toxin. The chili sauce was associated with a botulism outbreak and analysis of a sample of the chili sauce by FDA detected botulinum toxin type A in intact cans.
VOLUME OF PRODUCT IN COMMERCE
1,653,403 cases (39,681,672 cans)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) "SOY DELI Five Spice ORGANIC BAKED TOFU...Net Wt 8 oz...PERISHABLE.
    KEEP REFRIGERATED OR FROZEN. Vacuum packed in plastic, Recall # F-103-8;
b) "SOY DELI Hickory ORGANIC BAKED TOFU...Net Wt 8 oz...PERISHABLE.
    KEEP REFRIGERATED OR FROZEN". Vacuum packed in plastic, Recall # F-104-8;
c) "SOY DELI Honey Sesame ORGANIC BAKED TOFU...Net Wt 8 oz.
    PERISHABLE. KEEP REFRIGERATED OR FROZEN". Vacuum packed in plastic,
    Recall # F-105-8;
d) "SOY DELI Teriyaki ORGANIC BAKED TOFU...Net. Wt. 8 oz. PERISHABLE.
    KEEP REFRIGERATED OR FROZEN”. Vacuum packed in plastic, Recall # F-106-8;
e) "SOY DELI Savory ORGANIC BAKED TOFU...Net Wt 8 oz. PERISHABLE. KEEP
    REFRIGERATED OR FROZEN". Vacuum packed in plastic, Recall # F-107-8;
f) SOY DELI Mesquite all natural SMOKED TOFU...Net Wt 7 oz...PERISHABLE.
    KEEP REFRIGERATED". Vacuum packed in plastic, Recall # F-108-8;
g) "SOY DELI Hawaiian Style all natural FRIED TOFU...Net Wt 7 oz...PERISHABLE.
    KEEP REFRIGERATED". Vacuum packed in plastic, Recall # F-109-8;
h) "SOY DELI FIRM ORGANIC NIGARI TOFU...PERISHABLE KEEP
    REFRIGERATED". Net Wt 8 oz or 12 oz. Vacuum packed in plastic,
    Recall # F-110-8;
i) "SOY DELI All-Natural Tofu Burgers ORIGINAL Net Wt 6 oz... PERISHABLE.
    KEEP REFRIGERATED OR FROZEN ". Vacuum packed in plastic.
    Recall # F-111-8;
j) "SOY DELI All-Natural Tofu Burgers GARDEN Net Wt 6 oz... PERISHABLE.
    KEEP REFRIGERATED OR FROZEN. Vacuum packed in plastic, Recall # F-112-8;
k) "SOY DELI All-Natural Tofu Burgers BARBEQUE Net Wt 6 oz... PERISHABLE.
    KEEP REFRIGERATED OR FROZEN". Vacuum packed in plastic, Recall # F-113-8;
l) "SOY DELI All-Natural Tofu Burgers TERIAKI…Net Wt 6 oz... PERISHABLE.
    KEEP REFRIGERATED OR FROZEN". Vacuum packed in plastic. Recall # F-114-8;
m) "SOY DELI All-Natural Tofu Burgers CAJUN Net Wt 6 oz... PERISHABLE.
    KEEP REFRIGERATED OR FROZEN". Vacuum packed in plastic,
    Recall # F-115-8;
n) "SOY DELI FIRM ORGANIC -Gourmet Rich- CALCIUM TOFU... Net Wt 12 oz.
    PERISHABLE. KEEP REFRIGERATED. Water packed in plastic. Primarily orange-
    colored label, Recall # F-116-8;
o) "SOY DELI SOFT ORGANIC -Gourmet Rich- CALCIUM TOFU... Net Wt 12 oz.
    PERISHABLE. KEEP REFRIGERATED. Water packed in plastic. Primarily blue-
    colored label, Recall # F-117-8;
p) "SOY DELI FIRM ORGANIC NIGARI TOFU... Net Wt 12 oz. PERISHABLE.
    KEEP REFRIGERATED. Water packed in plastic. Primarily red-colored label,
    Recall # F-118-8;
q) "QUONG HOP... ORGANIC NIGARI TOFU firm style non-pasteurized. Net Wt 16
    oz. PERISHABLE KEEP REFRIGERATED. Water packed in plastic. Primarily red-
    colored label, Recall # F-119-8;
r) "SOY DELI FIRM ORGANIC NIGARI TOFU...PERISHABLE KEEP
    REFRIGERATED OR FROZEN... Net Wt 30 oz. Vacuum packed in plastic,
    Recall # F-120-8;
s) "SOY DELI NIGARI BULK TOFU" 10 lb, Recall # F-121-8;
t) "SOY DELI NIGARI MEDIUM BULK TOFU" 10 lb, Recall # F-122-8;
u) "NIGARI FIRM TOFU 54 PC" 10 lb (cut into 4 oz square pieces), Recall # F-123-8;
v) "SOY DELI NIGARI FIRM BULK TOFU" 10 lb or 20 lb, Recall # F-124-8;
w) "SOY DELI SOY LOWER CARB RAVIOLI" SOY PASTA, 12 oz, Recall # F-125-8;
x) "SOY DELI SOY LOWER CARB TORTELLINI" SOY PASTA, 12 oz,
    Recall # F-126-8;
y) "SOY DELI SOY LOWER CARB MANICOTTI" SOY PASTA, 12 oz,
    Recall # F-127-8
CODE
a) thru m) "JAN 28 2008" OR EARLIER;
n) thru y) "NOV 28 2007" OR EARLIER
RECALLING FIRM/MANUFACTURER
Quong Hop and Co., South San Francisco, CA, by telephone, fax letters, visits and press release beginning on September 18, 2007. Firm initiated recall is ongoing.
REASON
Products may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Not available
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Theophyline Extended-Release Capsules USP, 200 mg, 100-capsule bottle, Rx only, NDC-0258-3634-01 and 0456-4302-01, Recall # D-081-2008
CODE
Lot #: 6D005, exp. 2/12/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Laboratories, Inc., Commack, NY, by letters on December 14, 2007.
Manufacturer: Inwood Labs, Inwood, NY. Firm initiated recall is ongoing.
REASON
Product does not meet specifications for dissolution.
VOLUME OF PRODUCT IN COMMERCE
37,341 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100. All Alaris Pump modules shipped prior to September 27, 2007 are subject to this recall. Recall # Z-0460-2008
CODE
Serial Numbers: Affected Ranges 2326101 to 12492744; 12492756 to 12504708; 12504710 to 12507035; 12507042 to 12515453; 12515455 to 12618060; 12518062 to 12538350; 12538352 to 12547112; 12547114 to 12554430; 12554432 to 12555569; 12555574 to 12561325; 12561327 to 12564066; 12564068 to 12567998; 12568000 to 12571511; 12571521 to 12571809; 12571812 to 12572416; 12572425 to 12572530; 12572532 to 12572593; 12572595 to 12574101; 12574103 to 12575903; 12575905 to 12577208; 12577211 to 12577426; 12577429 to 12577597; 12577599 to 12578297; 12578299 to 12579448; 12579450 to 12583418; 12583420 to 12583440; 12583442 to 12583736; 12583738 to 12587206; 12587211 to 12590508; 12590533 to 12591688; 12591690 to 12591742; 12591744 to 12593449; 12593451 to 12594240; 12594242 to 12594422; 12594424 to 12594426; 12594428 to 12594603; 12594605 to 12594631; 12594633 to 12594889; 12594906 to 12595917; 12595919 to 12596254; 12596266 to 12596298; 12596300 to 12597075; 12597077 to 12597134; 12597136 to 12597176; 12597178 to 12597227; 12597244 to 12597404; 12597418 to 12597443; 12597457 to 12597537; 12597543 to 12597677; 12597699 to 12597701; 12597703 to 12598020; 12598022 to 12598103; 12598105 to 12598143; 12598145 to 12598168; 12598170 to 12598172; 12598174 to 12598269; 12598271 to 12598300; 12598302 to 12598319; 12598322 to 12598350; 12598352 to 12598388; 12598390 to 12598393; 12598395; 12598397 to 12598401; 12598403 to 12598414; 12598425; 12598429 to 12598438; 12598441 to 12598581; 12598583 to 12598588; 12598592 to 12598662; 12598665 to 12598667; 12598669 to 12598684; 12598686 to 12598733; 12598735; 12598737 to 12598787; 12598789 to 12598795; 12598797 to 12598827; 12598829 to 12598846; 12598848 to 12598864; 12598866 to 12598872; 12598881; 12598883 to 12598888; 12598890 to 12598892; 12598894 to 12599023; 12599025 to 12599027; 12599033; 12599036; 12599038 to 12599040; 12599042 to 12599046; 12599048 to 12599071; 12599074; 12599076 to 12599083; 12599085 to 12599086; 12599089 to 12599090; 12599092 to 12599093; 12599101; 12599106 to 12599107; 12599109; 12599111 to 12599113; 12599115 to 12599117; 12599122; 12599124 to 12599150; 12599152 to 12599154; 12599158 to 12599161; 12599163 to 12599165; 12599169 to 12599201; 12599204; 12599206; 12599209 to 12599210; 12599214; 12599218; 12599220 to 12599222; 12599234; 12599237; 12599240 to 12599241; 12599252; 12599254; 12599256; 12599258; 12599263 to 12599266; 12599303; 12599313 to 12599314; 12599316 to 12599324; 12599329 to 12599331; 12599341; 12599347; 12599357 to 12599359; 12599362 to 12599370; 12599372; 12599379 to 12599382; 12599385 to 12599387; 12599390; 12599392 to 12599454; 12599465 to 12599468; 12599476 to 12599505; 12599541 to 12599619; 12599621 to 12599668; 12599672; 12599674 to 12599723; 12599725 to 12599754; 12599756 to 12599845; 12599847 to 12599874; 12599876 to 12602723; 12602729 to 12602926; 12602944 to 12603127; 12603427 to 12603462; 12603472 to 12603550; 12603552 to 12604635; 12604637 to 12604638; 12604640 to 12604653; 12604662 to 12604715; 12604717 to 12604718; 12604723; 12604725 to 12604726; 12604728 to 12604731; 12604733 to 12604744; 12604749 to 12604985; 12604996 to 12605071; 12605073 to 12605340; 12605342 to 12605384; 12605386 to 12605411; 12605424 to 12605503; 12605510 to 12605519; 12605526 to 12605720; 12605722 to 12605778; 12605780 to 12605818; 12605825; 12605827 to 12605855; 12605857 to 12606012; 12606015; 12606018 to 12606022; 12606024; 12606027; 12606029 to 12606103; 12606105 to 12606148; 12606150 to 12606152; 12606154 to 12606163; 12606165 to 12606171; 12606173 to 12606262; 12606264 to 12606278; 12606280 to 12606399; 12606407 to 12606409; 12606412 to 12606417; 12606420; 12606425; 12606431 to 12606437; 12606439 to 12606518 ; 12606531 to 12606589; 12606591 to 12606606; 12606608 to 12606627; 12606630; 12606639 to 12606640; 12606642 to 12606646; 12606648 to 12606650; 12606652 to 12606684; 12606686 to 12606723; 12606733 to 12606755; 12606757; 12606759 to 12606770; 12606791 to 12606794; 12606798 to 12606799; 12606802 to 12606807; 12606809 to 12606820; 12606822 to 12606823; 12606830 to 12606853; 12606855; 12606878 to 12606880; 12606882 to 12606895; 12606898 to 12606932; 12606934 to 12606947; 12606952 to 12606972; 12606974 to 12606980; 12606982 to 12606983; 12606985 to 12606986; 12606988 to 12606989; 12606991 to 12606993; 12607015 to 12607027; 12607035 to 12607036; 12607039; 12607041 to 12607043; 12607055; 12607058; 12607066 to 12607127; 12607129; 12607131; 12607134 to 12607137; 12607139; 12607141 to 12607155; 12607157 to 12607158; 12607160 to 12607256; 12607258 to 12607260; 12607262 to 12607299; 12607301 to 12607350; 12607352 to 12607418; 12607420 to 12607429; 12607431; 12607435; 12607437 to 12607458; 12607461 to 12607464; 12607466; 12607472 to 12607473; 12607475 to 12607485; 12607487 to 12607574; 12607576 to 12607632; 12607634 to 12607733; 12607735 to 12607741; 12607743 to 12607747; 12607749 to 12607817; 12607820 to 12607826; 12607828 to 12607846; 12607849 to 12607853; 12607860 to 12607863; 12607865 to 12607866; 12607868 to 12607925; 12607931; 12607941 to 12608002; 12608004; 12608013 to 12608015; 12608019; 12608022 to 12608031; 12608033 to 12608037; 12608039; 12608041 to 12608118; 12608126 to 12608127; 12608129 to 12608194; 12608196 to 12608261; 12608263 to 12608267; 12608269 to 12608343; 12608356; 12608358 to 12608360; 12608362 to 12608366; 12608368 to 12608377; 12608379 to 12608380; 12608397 to 12608398; 12608400 to 12608402; 12608404 to 12608408; 12608411 to 12608423; 12608426 to 12608428; 12608430; 12608444; 12608446 to 12608447; 12608462 to 12608474; 12608487 to 12608546; 12608548 to 12608554; 12608556 to 12608558; 12608560 to 12608575; 12608577 to 12608578; 12608580 to 12608596; 12608603 to 12608611; 12608613 to 12608616; 12608618; 12608621; 12608624 to 12608665; 12608667 to 12608693; 12608696 to 12608706; 12608718 to 12608724; 12608727; 12608731 to 12608758; 12608762 to 12608766; 12608770 to 12608774; 12608776 to 12608811; 12608813 to 12608825; 12608828 to 12608894; 12608898 to 12608901; 12608903 to 12608945; 12608948 to 12608972; 12608974 to 12609112; 12609136 to 12609155; 12609157; 12609159 to 12609162; 12609189 to 12609255; 12609257 to 12609262; 12609264 to 12609285; 12609288 to 12609302; 12609304 to 12609305; 12609307 to 12609309; 12609311 to 12609332; 12609334 to 12609356; 12609369 to 12609371; 12609375; 12609382 to 12609389; 12609393 to 12609440; 12609442; 12609445 to 12609449; 12609451; 12609453; 12609455 to 12609467; 12609469 to 12609478; 12609480 to 12609810; 12609812 to 12609853; 12609855 to 12609869; 12609871 to 12609926; 12609928; 12609945 to 12610030; 12610035 to 12610037; 12610039; 12610042 to 12610043; 12610047 to 12610103; 12610105 to 12610131; 12610133 to 12610145; 12610147 to 12610148; 12610150 to 12610151; 12610153 to 12610160; 12610172 to 12610178; 12610180 to 12610181; 12610183 to 12610208; 12610216 to 12610222; 12610224 to 12610225; 12610227; 12610229 to 12610231; 12610250 to 12610227; 12610279 to 12610281; 12610283; 12610295 to 12610321; 12610324 to 12610332; 12610334 to 12610356; 12610358 to 12610376; 12610378 to 12610383; 12610386 to 12610409; 12610411 to 12610421; 12610424 to 12610452; 12610454; 12610456 to 12610484; 12610497 to 12610583; 12610585 to 12610634; 12610636 to 12610641; 12610644; 12610647 to 12610669; 12610672 to 12610679; 12610692 to 12610699; 12610710 to 12610784; 12610795 to 12610798; 12610800 to 12610848; 12610850 to 12610870; 12610872; 12610893 to 12611013; 12611015 to 12611017; 12611029; 12611031 to 12611034; 12611037 to 12611044; 12611046 to 12611047; 12611049 to 12611078; 12611080 to 12611082; 12611084 to 12611106; 12611109 to 12611111; 12611128 to 12611129; 12611132 to 12611147; 12611149; 12611152; 12611154 to 12611158; 12611161 to 12611162; 12611164 to 12611194; 12611196 to 12611203; 12611304; 12611308 to 12611309; 12611311 to 12611312; 12611333 to 12611336; 12611338 to 12611341; 12611343; 12611345 to 12611346; 12611350 to 12611354; 12611357; 12611403 to 12611405; 12611410 to 12611411; 12611421 to 12611422; 12611427 to 12611428; 12611430; 12611442; 12611445 to 12611447; 12611451 to 12611460; 12611463 to 12611467; 12611471 to 12611478; 12611483; 12611488 to 12611489; 12611499 to 12611500; 12611502; 12611505 to 12611522; 12611524 to 12611526; 12611528 to 12611529; 12611532; 12611534 to 12611535; 12611538 to 12611550; 12611553 to 12611557; 12611561 to 12611563; 12611565 to 12611591; 12611593; 12611634; 12611641 to 12611643; 12611646 to 12611679; 12611684 to 12611686; 12611690 to 12611693; 12611695 to 12611697; 12611733 to 12611735; 12611739 to 12611741; 12611748 to 12611783; 12611791 to 12611794; 12611799 to 12611803; 12611805; 12611818; 12611820; 12611825 to 12611828; 12611830 to 12611832; 12611849 to 12611852; 12611854; 12611862; 12611865 to 12611878; 12611892 to 12611991; 12612002 to 12612003; 12612005 to 12612015; 12612017; 12612019; 12612021 to 12612022; 12612024; 12612026 to 12612064; 12612066 to 12612082; 12612084 to 12612089; 12612091; 12612093; 12612095 to 12612098; 12612101 to 12612123; 12612128 to 12612132; 12612134 to 12612135; 12612154 to 12612163; 12612165 to 12612190; 12612193 to 12612194; 12612196 to 12612199; 12612201 to 12612219; 12612222; 12612224 to 12612225; 12612227 to 12612230; 12612235 to 12612237; 12612239 to 12612267; 12612269 to 12612280; 12612282 to 12612290; 12612293 to 12612305; 12612307 to 12612321; 12612335 to 12612337; 12612395 to 12612397; 12612399; 12612401 to 12612404; 12612407 to 12612415; 12612417 to 12612419; 12612421 to 12612428; 12612430 to 12612431; 12612433; 12612435 to 12612439; 12612460 to 12612463; 12612491; 12612498; 12612506 to 12612509; 12612511; 12612519; 12612521; 12612524 to 12612527; 12612541 to 12612542; 12612544 to 12612568; 12612570; 12612573; 12612575; 12612578 to 12612616; 12612618 to 12612627; 12612636; 12612638 to 12612639; 12612643 to 12612649; 12612656 to 12612663; 12612665; 12612680 to 12612690; 12612692; 12612703; 12612713 to 12612728; 12612735 to 12612758; 12612760 to 12612764; 12612766 to 12612772; 12612775 to 12612784; 12612786 to 12612794; 12612797 to 12612810; 12612812 to 12612815; 12612817 to 12612821; 12612823 to 12612933; 12612935 to 12612939; 12612945; 12612948 to 12612958; 12612960 to 12612962; 12612965 to 12612968; 12612970 to 12612976; 12612978 to 12612989; 12612991 to 12613002; 12613004 to 12613021; 12613023 to 12613024; 12613027 to 12613028; 12613030 to 12613034; 12613036; 12613038 to 12613046; 12613048 to 12613050; 12613056; 12613060 to 12613065; 12613067 to 12613076; 12613078 to 12613079; 12613083 to 12613084; 12613087 to 12613088; 12613092; 12613098; 12613102; 12613104 to 12613105; 12613110; 12613114; 12613117 to 12613120; 12613123; 12613132 to 12613134; 12613137; 12613140 to 12613141; 12613145; 12613149; 12613152; 12613155 to 12613156; 12613160 to 12613161; 12613165 to 12613168; 12613204; 12613227; 12613238; 12613264 to 12613265; 12613274; 12613277; 12613336; 12613383 to 12613406; 12613412 to 12613413; 12613416; 12613419; 12613426; 12613430; 12613442 to 12613443; 12613449; 12613470; 12613475; 12613531; 12613587; 12613605; 12613644 to 12613645; 12613651; 12613655; 12613768 to 12613769; 12613797 to 12613813; 12613815 to 12613818; 12613821 to 12613839; 12613873; 12613876 to 12613883; 12613890; 12613893 to 12613894; 12613896; 12613898; 12613938; 12613940 to 12613954; 12613979 to 12613981; 12613989 to 12613990; 12613992 to 12613999; 12614001; 12614003 to 12614025; 12614027; 12614037; 12614039; 12614116; 12614118; 12614125; 12614130; 12614133; 12614138; 12614145; 12614147; 12614174 to 12614175; 12614236; 12614240; 12614247; 12614259 to 12614261; 12614276; 12614297; 12614324 to 12614325; 12614354; 12614365; 12614378; 12614403; 12614405; 12614424; 12614475; 12614700; 12614981; 12614985; 12614989; 12614991; 12615004; 12615023 to 12615024; 12615026; 12615038; 12615055; 12615097; 12615109; 12615121; 12615133; 12615159; 12615226; 12615276; 12615290; 12615345 to 12615346; 12615363; 12615410; 12615412; 12615416 to 12615417; 12615419; 12615423; 12615425 to 12615426; 12615442; 12615466; 12615468; 12615497; 12615596; 12615601; 12615609 to 12615610; 12615615; 12615680; 12615686 to 12615688; 12615719 to 12615720; 12615722 to 12615723; 12615727; 12615736; 12615738; 12615872; 12615888; 12615898 to 12615900; 12615913 to 12615937; 12615952; 12615961 to 12615962; 12615964; 12615994; 12615996; 12616012; 12616018; 12616043 to 12616044; 12616090; 12616098; 12616109 to 12616113; 12616131; 12616179; 12616212 to 12616214; 12616245; 12616267; 12616276; 12616323; 12616379 to 12616383; 12616385; 12616387 to 12616389; 12616402 to 12616403; 12616411; 12616444; 12616452 to 12616453; 12616457; 12616459 to 12616476; 12616478; 12616493; 12616496 to 12616510; 12616519 to 12616520; 12616542; 12616544 to 12616545; 12616550; 12616585; 12616590; 12616615; 12616617 to 12616618
RECALLING FIRM/MANUFACTURER
Cardinal Health 303 Inc DBA Alaris Products, San Diego, CA, by letters on November 5, 2007. Firm initiated recall is ongoing.
REASON
Inaccurate flow rate; related to misassembled (missing, bent or broken) springs during the manufacturing or servicing of the mechanism assembly.
VOLUME OF PRODUCT IN COMMERCE
203,277 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
a) Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Recall # Z-0246-2008;
b) Biograph 40 - 3 Ring, Biograph PET/CT Scanner, Catalog No. 10097233,
    Recall # Z-0247-2008;
c) Biograph 40 TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303,
    Recall # Z-0248-2008;
d) Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728854, Recall # Z-0249-2008;
e) Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728573, Recall # Z-0250-2008;
f) Biograph 64-3 Ring, Biograph PET/CT Scanner, Catalog No. 8727450,
    Recall # Z-0251-2008;
g) Biograph DUO LSO, Biograph PET/CT Scanner, Catalog No. 8728813,
    Recall # Z-0252-2008
CODE
a) Serial Numbers: 1300, 1301, 1302, 1303, 1305, 1306, 1307, 1308, 1309, 1310, 1311,   1312, 1313, 1315, 1316, 1317, 1318, 1319, 1320, 1321, 1322, 1323, 1324, 1325, 1326, 1327, 1328, 1329, 1330, 1331, 1332, 1333, 1334, 1335, 1336, 1337, 1338, 1340, 1341, 1342, 1343, 1344, 1345, 1346, 1347, 1348, 1349, 1350, 1351, 1352, 1353, 1354, 1355, 1356, 1357, 1359, 1360, 1361, 1362, 1363, 1364, 1365, 1366, 1367, 1368, 1369, 1370, 1371, 1372, 1373, 1374, 1375, 1376, 1377, 1378, 1379, 1380, 1381, 1382, 1383, 1384, 1385, 1386, 1387, 1388, 1389, 1391, 1392, 1393, 1394, 1395, 1396, 1397, 1398, 1399, 1400, 1401, 1402, 1403, 1404, 1405, 1406, 1407, 1408, 1409, 1410, 1411, 1412, 1413, 1414, 1415, 1416, 1417, 1418, 1419, 1420, 1421, 1422, 1424, 1425, 1427, 1428, 1429, 1430, 1431, 1432, 1433, 1434, 1435, 1436, 1437, 1438, 1439, 1442, 1443, 1444, 1445, 1446, 1447, 1448, 1449, 601055, 701068, 701069, P0007130-0401002, P0007130-0401003, P0007130-0401004, P0007130-0401005, P0007130-0401006, P0007130-0401007, P0007130-0401008, P0007130-0401009, P0007130-0401010, P0007130-0401012, P0007130-0401013, P0007130-0401014, P0007130-0401015, P0007130-0401016, P0007130-0401021, P0007130-0401031, P0007130-0501056, and P0007130-0501075;
b) Serial Numbers: 1001, 1002, 1003, 1004, 1005, 1007, 1008, 1009, 1012, 1013, and 1014;
c) Serial Numbers: 1001, 1002, and 1003;
d) Serial Numbers: 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1307, 1309, 1310, 1311, 1312, 1313, 1315, 1316, 1317, 1318, 1320, 1321, 1322, 1323, 1324, 1325, 1326, 1327, 1329, 1330, 1331, 1332, 1333, 1334, 1335, 1336, 1337, 1338, 1339, 1340, 1341, 1342, 1343, 1344, 1345, 1346, 1347, 1348, 1349, 1350, 1351, 1352, 1353, 1354, 1355, 1356, 1357, 1358, 1359, 1360, 1361, 1362, 1363, 1364, 1365, 1366, 1367, 1368, 1369, 1370, 1371, 1372, 1373, 1374, 1375, 1376, 1377, 1378, 1379, 1380, 1381, 1382, 1383, 1384, 1385, 1386, 1387, 1388, 1389, 1390, 1391, 1392, 1393, 1394, 1395, 1396, 1397, 1398, 1399, 1400, 1401, 1402, 1403, 1404, 1405, 1406, 1407, 1408, 1409, 1410, 1411, 1412, 1413, 1414, 1415, 1416, 1417, 1418, 1419, 1420, 1421, 1422, 1423, 1424, 1425, 1426, 1427, 1428, 1429, 1430, 1431, 1432, 1433, 1434, 1435, 1436, 1437, 1438, 1439, 1440, 1441, 1442, 1443, 1444, 1445, 1446, 1447, 1448, 1450, 1451, 1452, 1455, 1456, 1457, 1458, 1459, 1460, 1461, 1462, 1464, 1465, 1466, 1467, 401011, 401013, 401030, 601033, 701065, 701073, P0006939-0401004, P0006939-0401006, P0006939-0401009, P0006939-0401015, P0006939-0401016, P0006939-0401017, P0006939-0401026, and P0006939-0401034;
e) Serial Numbers: 401010, 401014, P0006939-0401002, P0006939-0401007, P0006939-0401008, and P0006939-0401012;
f) Serial Numbers: 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1010, 1012, 1013, 1014, 1015, 1016, 1017, 1018, and 1019;
g) Serial Numbers: 1322, 1323, 1324, 1325, 1326, 1327, 1328, 1329, 1330, 1331, 1332, 1333, 1334, 1335, 1336, 1337, 1338, 1339, 1340, 1341, 1342, 1343, 1344, 1345, 1346, 1348, 1349, 1350, 1352, 1353, 1354, 1355, 1356, 1357, 1359, 1360, 1362, 1363, 1364, 1365, and 1366
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA Inc., Knoxville, TN, by letter dated June 15, 2007. Firm initiated recall is ongoing.
REASON
Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols).
VOLUME OF PRODUCT IN COMMERCE
414 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, (the syringe is packaged in a white box and sealed with a label wrapped around the center of the box-The main analyzer list number is 08H00-01, ), Recall # Z-0301-2008
CODE
Package Dates (printed on syringe label); 08 May 2007 to 25 June 2007
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letter on July 24, 2007. Firm initiated recall is ongoing.
REASON
Syringe Failure. Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter.
VOLUME OF PRODUCT IN COMMERCE
302 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
bioMerieux, BacT/ALERT® FA Culture Bottles, Recall # Z-0457-2008
CODE
Lot Numbers: 1017685, 101793 and 1017788
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc., Durham, NC, by letter on November 5, 2007. Firm initiated recall is ongoing.
REASON
Duplicate Bottle Indentification -- Three lot numbers of BacT/ALERT® FA Culture Bottles labels contained duplicate bottle identification (Bottle ID) barcode numbers. (Lots 1017685 and 1017788 contain the same series of Bottle ID's; Lot 1017693 contains duplicate Bottle ID's within the lot and may share Bottle ID's with both lots 1017685 and 1017788)
VOLUME OF PRODUCT IN COMMERCE
7,025 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
HAENG LIM --Acupuncture Needles- PRE-STERILIZED GAMMA-RAY; 100 Packages (10 Needles/Package-1,000 needles in each box), Recall # Z-0566-2008
CODE
All Lot Numbers and Serial Numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Marknew Products, Santa Fe Springs, CA, by letters on November 27, 2007.
Manufacturer: Haeng Lim Seo Won, Wonmiku Buchon, Korea, Republic Of (South). Firm initiated recall is ongoing.
REASON
Marketed without 510(k)
VOLUME OF PRODUCT IN COMMERCE
320-380 boxes/100 packages (10 needles/package)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part Numbers: 842-673800, 842-673900, 982A0421 and
982A0422, Recall # Z-0126-2008
CODE
ON040060, ON050120, ON050130, ON050168, ON050186, ON050197, ON050199, ON050203, ON050206, ON050212, ON050220, ON050231, ON060232, ON060243, ON060254, ON060256, ON060257, ON060269, ON060270, ON060272, ON060275, ON060276, ON060277, ON060278, ON060279, ON060280, ON060288, ON060290, ON060291, ON060292, ON060299, ON070301, ON070308
RECALLING FIRM/MANUFACTURER
Nicolet Biomedical Division of Viasys Healthcare, Madison, WI, by letter on September 11, 2007. Firm initiated recall is ongoing.
REASON
Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option.
VOLUME OF PRODUCT IN COMMERCE
33 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR JANUARY 9, 2008

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