July 16, 2003
03-29
__________________________
PRODUCT
Nut Country Products that can pose an acute, life-threatening hazard to health:
a) Country Crunch - undeclared soy flour;
b) Dark Chocolate Coffee Beans - undeclared milk;
c) Easter Jubilee Mix - undeclared whey, wheat flour,
FD&C Blue #1, Blue #1 Lake, Red #40 Lake, and Yellow #5
Lake;
d) Holly Mix - undeclared egg whites and FD&C Red #40;
e) Mustard Pretzels - undeclared non-fat milk and soy
flour.
Recall # F-437-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Nut Country, USA Visalia, CA, by letters via mail and telephone, beginning September 23, 2002. FDA initiated recall is complete.
REASON
Products contain undeclared ingredients including allergens and colors.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
CA.
______________________________
PRODUCT
Nut Country Products that contain undeclared FD&C Yellow No. 5/6 or
their corresponding lakes:
a) Candy Corn - undeclared FD&C Red #40 and Yellow #6;
b) Cinnamon Imperials - undeclared FD&C Yellow #6, Red #40,
and Red #40 Lake;
c) Cinnamon Jells - undeclared FD&C Red #3, Red #40, and
Yellow #6;
d) Dried Papaya - undeclared FD&C Yellow #5 and Yellow #6;
e) Fire Starter - undeclared FD&C Yellow #6 (found in Chili
Bits);
f) GORP - undeclared FD&C Yellow #5 Lake, Yellow #6 Lake,
Blue #2 Lake, Red #40 Lake, Blue #1 Lake, and Yellow #6;
g) Gummy Treats - undeclared FD&C Blue #1 and Yellow #6;
h) Hawaiian Luau - undeclared FD&C Yellow #5 and Yellow #6
(contains dried papaya);
i) Assorted Jumbo Jellies - undeclared FD&C Blue #1, Red
#3, Red #40, and Yellow #5;
j) Orange Slices - undeclared FD&C Yellow #6 and Red #3;
k) Really Sour Sours - undeclared FD&C Blue #1, Blue #2,
Red #40, and Yellow #6;
l) Sweet and Sour Eggs - undeclared FD&C Yellow #6.
Recall # F-438-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Nut Country, USA Visalia, CA, by letters via mail and telephone, beginning September 23, 2002. FDA initiated recall is complete.
REASON
Products contain undeclared ingredients including allergens and colors.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
CA.
______________________________
PRODUCT
Nut Country Products that are unlikely to pose a hazard to health:
a) Atomic Fireballs - undeclared FD&C Red #40 Lake;
b) Black Jelly Beans - undeclared FD&C Yellow #6 Lake,
Blue #2 Lake, and Red #40 Lake;
c) Boston Baked Beans - undeclared FD&C Red #3, Red #40,
Blue #2, and Red #40 Lake;
d) Burnt Peanuts - undeclared FD&C Red #3, Red #40, and
Blue #2
e) Cheddar Oat Bran Mix - undeclared ingredients;
f) Chicken Bones - undeclared ingredients including FD&C
Blue #2 Lake, Red #40 Lake, Yellow #5 Lake, and Yellow
#6 Lake;
g) Chocolate Butter Toffee Peanuts - undeclared ingredients;
h) Chocolate Covered Almonds - undeclared ingredients;
i) Chocolate Covered Peanuts - undeclared ingredients;
j) Chocolate Covered Raisins - undeclared ingredients;
k) Chocolate English Toffee - undeclared ingredients;
l) Chocolate Pretzels - undeclared ingredients;
m) Cinnamon Bears - undeclared FD&C Red #40;
n) Easter Bunny Kisses - undeclared FD&C Blue #1 and Red
#3;
o) Fiesta Del Sol - undeclared ingredients;
p) Gems - undeclared ingredients including FD&C Yellow #5
Lake, Yellow #6 Lake, Blue #1 Lake, Blue #2 Lake, and
Red #40 Lake;
q) Jelly Beans - undeclared ingredients including FD&C Red
#40, Red #3, Blue #1, Blue #2, Blue #1 Lake, Blue #2
Lake, Yellow #6 Lake, and Red #40 Lake;
r) Jolly Rancher - undeclared FD&C Red #40 and Blue #1;
s) Malted Milk Balls - undeclared ingredients;
t) Mini Pretzels - undeclared ingredients;
u) Mint Pearls - undeclared FD&C Yellow #5 Lake, and Blue
#1 Lake;
v) "Mug Puckers" Really Sour Gum - undeclared FD&C Blue #1
and Red #40;
w) Pecan Sun Clusters - undeclared ingredients;
x) Premium Jordan Almonds - undeclared ingredients;
y) Salt Water Taffy - undeclared FD&C Blue #1, Red #3, and
Red #40;
z) Sesame Honey Crunch - undeclared ingredients;
aa)Sour Strawberry Straws - undeclared ingredients;
bb)Speckled Malt Eggs - undeclared ingredients including
FD&C Blue #1, Blue #1 Lake, Red #40, Red #40 Lake, and
Yellow #5 Lake;
cc)Starlite Mints - undeclared FD&C Red #40;
dd)Sugarless Chocolate Raisins - undeclared ingredients;
ee)Valentine Conversation Hearts - undeclared FD&C Red #40
Lake, Yellow #5 Lake, Yellow #6 Lake, Blue #1 Lake, and
Blue #2 Lake;
ff)Valentine Jelly Beans - undeclared FD&C Red #3 and
Red #40;
gg)Yogurt Almonds - undeclared non-fat dry milk, however,
a milk-sensitive individual would avoid the product
based on the product's identification as "Yogurt" and
the listing of yogurt as an ingredient;
hh)Yogurt Pretzels - undeclared non-fat dry milk, however,
a milk-sensitive individual would avoid the product
based on the product's identification as "Yogurt" and
the listing of yogurt as an ingredient;
ii)Yogurt Raisins - undeclared non-fat dry milk, however,
a milk-sensitive individual would avoid the product
based on the product's identification as "Yogurt" and
the listing of yogurt as an ingredient.
Recall # F-439-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Nut Country, USA Visalia, CA, by letters via mail and telephone, beginning September 23, 2002. FDA initiated recall is complete.
REASON
Products contain undeclared ingredients including allergens and colors.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
CA.
***CORRECTION***
The Enforcement Report of July 9, 2003 for Class III Drugs,
Coppertone Bug & Sun Recall # D-271/272-3 states that the reasons for the recall
are:
a) Incorrect inactive ingredient; product contains Benzophenone-4 rather than Benzophenone-3;
b) Product contains undeclared preservative.
Preferred wording is:
a) These lots contain trace quantities of an additional
sunscreen, benzophenone-4, which were incorrectly added to
the formulation.
b) Certain lots of product may contain undeclared preservative.
The Manufacturer is Prime Enterprises, Inc., Miami Lakes, FL, not Schering-Plough Health Care Products, Cleveland, TN.
______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1137-3.
CODE
Unit number 01GP36549.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by fax and letter dated September 16, 2002 and October 22, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1270-3;
b) Plasma. Recall # B-1271-3.
CODE
a), and b) Units LL29757, LL28289.
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter on May 14, 2001.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MO, and CA.
______________________________
PRODUCT
Source Plasma. Recall # B-1279-3. (2 units),
CODE
Unit numbers 0090630898 and 0090631157.
RECALLING FIRM/MANUFACTURER
Nabi, Scranton, PA, by letter on August 12, 2002. Firm initiated recall
is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Korea.
______________________________
PRODUCT
Source Plasma. Recall # B-1280-3.
CODE
Unit number 0090630899.
RECALLING FIRM/MANUFACTURER
Nabi, Scranton, PA, by letter on August 12, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Korea.
______________________________
PRODUCT
Source Plasma. Recall # B-1282-3.
CODE
Unit numbers 74537709 and 74539390.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Everett, WA, by facsimile on May 13, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to previous incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
______________________________
PRODUCT
Human Tissue for Transplantation, Corneas.
Recall # B-1283-3.
CODE
Tissue numbers 007-02-019 and 007-02-020.
RECALLING FIRM/MANUFACTURER
East Tennessee Lions Eye Bank, Knoxville, TN, by letter on May 1, 2003. Firm initiated recall is complete.
REASON
Human tissue that was not tested for antibodies to human immunodeficiency virus, type 2 (anti-HIV-2) was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
TN.
______________________________
PRODUCT
Human Tissues for transplantation, Achilles Tendon.
Recall # B-1286-3.
CODE
Serial # 7345076.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia, by letter dated March 14, 2003. Firm initiated recall is ongoing.
REASON
Human tissues for transplantation, which were associated with a complaint of alleged microorganism infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
SD.
______________________________
PRODUCT
Human Tissues for transplantation, Saphenous Vein.
Recall # B-1287-3.
CODE
Serial # 7235647
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia, by letter dated March 14, 2003. Firm initiated recall is ongoing.
REASON
Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
______________________________
PRODUCT
Human Tissues for transplantation.
a) Femoral Vein with valve;
b) Saphenous Vein.
Recall # B-1288-3.
CODE
a) Serial # 7158918;
b) Serial # 7360291, 7332864, 7360271.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia, by letter dated April 17, 2003. Firm initiated recall is ongoing.
REASON
Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CA, FL, NY, and TX.
______________________________
PRODUCT
Human Tissues for transplantation, Saphenous Vein.
Recall # B-1300-3.
CODE
Serial # 7291004
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia, by letter dated May 28, 2003. Firm initiated recall is ongoing.
REASON
Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1320-3.
CODE
Unit numbers 7582235 (distributed as two split products), 7581111, and 5231694.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letters on September 12 and 13, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1324-3;
b) Platelets. Recall # B-1325-3;
c) Fresh Frozen Plasma (1 unit) Recall # B-1326-3.
CODE
a) Unit numbers 7848956 and 7797922;
b) Unit number 7797922;
c) Unit number 7848956.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on February 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Prednisone, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX, NY, and Switzerland.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1328-3.
CODE
Unit number 7547785.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on January 7, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, and Switzerland.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1330-3.
CODE
Unit number 7547419.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on January 8, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, and Switzerland.
______________________________
PRODUCT
Red Blood Cells. Recall B-1332-3.
CODE
Unit number 7547772.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on January 7, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, and Switzerland.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1334-3;
b) Cryoprecipitated AHF. Recall # B-1335-3.
CODE
a) and b) unit number 7445208.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carter BloodCare, Bedford, TX, by letter on June 15, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and Switzerland.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1338-3.
CODE
Unit number 7450164.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated November 15, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1339-3.
CODE
Unit number 5293106.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated January 9, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
______________________________
PRODUCT
Chiron ProcleixÔ System Computer Software. Recall # B-1340-3.
CODE
Version numbers 1.0.1.0, 3.0.3.4, and 2.1.2.0.
RECALLING FIRM/MANUFACTURER
Gen-Probe, Inc., San Diego, CA, by telephone on July 3, 2002, and by distribution of a technical bulletin on July 5, 2002. Firm initiated recall is ongoing.
REASON
A computer software defect could result in invalid calibrator results being used in the determination of assay validity and cut-off for HIV and HCV nucleic acid testing (NAT) test results.
VOLUME OF PRODUCT IN COMMERCE
3 versions.
DISTRIBUTION
Nationwide, France, New Zealand, Japan, and Singapore.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-1281-3.
CODE
Unit numbers 23147-0769, 23147-0777, 23147-0781, 23147-1510.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings, MT, by telephone on August 29, 2002. Firm initiated recall is complete.
REASON
Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
AL, and MT.
______________________________
PRODUCT
Human Tissues for transplantation. Recall # B-1285-3. a) Achilles Tendon;
b) Saphenous Vein.
CODE
a) Serial # 4265408;
b) Serial # 7239995.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia, by letter dated February 27, 2003. Firm initiated recall is complete.
REASON
Human tissues for transplantation, which were associated with a complaints of alleged microorganism infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AZ, CA, LA, and NB.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1317-3.
CODE
Unit number 11332-4739.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by telephone on May 6, 2002. Firm initiated recall is complete.
REASON
Unlicensed blood product was distributed interstate.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NM.
______________________________
PRODUCT
Platelets. Recall # B-1318-3;
Fresh Frozen Plasma. Recall # B-1319-3.
CODE
a) and b) unit number 7419315.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated January 29, 2002. Firm initiated recall is complete.
REASON
Blood products, manufactured from a unit of Whole Blood that had a discrepant collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1321-3;
b) Platelets. Recall # B-1322-3;
c) Recovered Plasma. Recall # B-1323-3.
CODE
a), b), and c) Unit number 5304199;
b) (unit was included in Platelet Pool #5186236).
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letters on February 26, 2002, and April 9, 2002, and by telephone on August 8, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX, and Switzerland.
______________________________
PRODUCT
Recovered Plasma. Recall # B-1327-3.
CODE
Unit number 7797922.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on February 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Prednisone, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, NY, and Switzerland.
______________________________
PRODUCT
Recovered Plasma. Recall # 1329-3.
CODE
Unit number 7547785.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on January 7, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, and Switzerland.
______________________________
PRODUCT
Recovered Plasma. Recall # B-1331-3.
CODE
Unit number 7547419.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on January 8, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, and Switzerland.
______________________________
PRODUCT
Recovered Plasma. Recall # B-1333-3.
CODE
Unit number 7547772.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on January 7, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, and Switzerland.
______________________________
PRODUCT
Recovered Plasma. Recall # B-1336-3.
CODE
Unit number 7445208.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carter BloodCare, Bedford, TX, by letter on June 15, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, and Switzerland.
______________________________
PRODUCT
Recovered Plasma. Recall # B-1337-3.
CODE
Unit number 7547777.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carter BloodCare, Bedford, TX, by letter on January 7, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland
______________________________
PRODUCT
Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden. Recall # Z-0908-03.
CODE
Serial numbers 81972 through 82063, and SEV0141098 through SEV0304112.
RECALLING FIRM/MANUFACTURER
Getinge/Castle, Inc., Rochester, NY, by letter dated March 25, 2003. Firm initiated
recall is ongoing.
REASON
Hot water may splash from the washer chamber creating a burn hazard.
VOLUME OF PRODUCT IN COMMERCE
75 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Evita 4 Continuous Ventilator. Catalog numbers 4116640 and 8412980. Recall # Z-0954-03.
CODE
Software version 4.00 or 4.10.
RECALLING FIRM/MANUFACTURER
Draeger Medical, Inc., Telford, PA, by letters dated May 7, 2003. Firm initiated recall is ongoing.
REASON
Software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.
VOLUME OF PRODUCT IN COMMERCE
806 units.
DISTRIBUTION
Nationwide, and Canada.
END OF ENFORCEMENT REPORT FOR JULY 16, 2003
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