FDA

Enforcement Report

July 21, 1999                                      99-29

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
a) Potato Salad; b) Cole Slaw; c) Fine Cole Slaw, manufactured 
and distributed in 5 pound and 10 pound plastic containers.  
Recall #F-560/562-9.
CODE
All potato salad distributed prior to 6/3/99 and all cole slaw 
and fine cole slaw distributed prior to 6/15/99.
MANUFACTURER
Frank L. Harter & Sons, Cincinnati, Ohio.
RECALLED BY
Manufacturer: a) by telephone on June 4, 1999, followed by visit, 
and by letter mailed beginning June 4, 1999; b&c) by telephone 
and by letter beginning on June 16, 1999. Completed field 
correction (relabeling) resulted from an inspection conducted by 
the Ohio Department of Agriculture (ODA).
DISTRIBUTION
Kentucky and Indiana.
QUANTITY
Approximately 800 pounds of potato salad and 150 pounds of cole 
slaw and fine cole slaw remained on market at time of recall 
initiation.
REASON
The Potato Salad contains undeclared egg yolks and undeclared 
FD&C Yellow No. 5.  The Cole Slaw and Fine Cole Slaw contain 
undeclared egg yolks.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
________
PRODUCT
Te Chang Food brand Spiced Dried Bean Curd, in 6 ounce boxes.  
Recall #F-541-9.
CODE
None.
MANUFACTURER
Grand Western Food Corporation, Taiwan.
RECALLED BY
Blooming Import Company, Inc., Brooklyn, New York, by letter on 
February 10, 1999.  Completed recall resulted from sample 
analysis and follow-up by the New York State Department of 
Agriculture and Markets.
DISTRIBUTION
New York.
QUANTITY
95 cartons (10 boxes per carton) were distributed.
REASON
Product contained the unapproved color additive Ponceau 4R.
________
PRODUCT
Pearl River Bridge brand Almond Cakes, in 10 ounce packages.  
Recall #F-542-9.
CODE
None.
MANUFACTURER
Guangdong Foodstuffs Import & Export Corporation, Peoples 
Republic of China.
RECALLED BY
Murray International Trading Company, Inc., Brooklyn, New York, 
by letter on April 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
50 cases (60 packages per case) were distributed.
REASON
Product contained undeclared FD&C Yellow No.5 and FD&C Blue No.1.
________
PRODUCT
a) CTF brand Pickled Mango in 16 ounce glass jars, Product of 
Thailand; b) CTF brand Pickled Lotus Rootlets, in 15 ounce glass 
jars, Product of Thailand.  Recall #F-547/548-9.
CODE
None.
MANUACTURER
a) Siam Tropical Product Limited Partnership, Bangkok, Thailand; 
b) Savoy Enterprise Limited Partnership., Bangkok, Thailand.
RECALLED BY
BCN Trading Inc., Brooklyn, New York (importer), by letter on 
January 12, 1999.  Completed recall resulted from sample analysis 
and follow-up by the New York State Department of Agriculture and 
Markets.
DISTRIBUTION
New York, Connecticut, Florida, District of Columbia, 
Massachusetts, New Jersey, Pennsylvania.
QUANTITY
a) 60 cartons (24 jars per carton); b) 200 cartons (24 jars per 
carton) were distributed.
REASON
a) Product contained undeclared FD&C Yellow No. 5;
b) Product contained undeclared sulfites and sodium benzoate.
________
UPDATE
Isomil, Ready-To-Feed Liquid Infant Formula, Recall F-537-9, 
which appeared in the July 14, 1999 Enforcement Report is a Class 
II recall.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
________
PRODUCT
Frozen Whole Eggs, in 30 pound plastic pails.
Recall #F-599-9.
CODE
Lot #A73388E.
MANUFACTURER
Estherville Foods, Inc., Estherville, Iowa.
RECALLED BY
Nulaid Foods, Inc., Ripon, California, by telephone on or about 
May 10, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
California, Hawaii, Nevada.
QUANTITY
1,805 pails were distributed.
REASON
The product contains a foreign object (a piece of equipment 
identified as a breaker cup assembly).

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II
________
PRODUCT
Trihexyphenidyl Hydrochloride Tablets, 5 mg, in 100 tablet 
blister strips of 10 tablets, Rx oral antispasmodic tablet used 
as an adjunct in the treatment of all forms of parkinsonism. NDC 
51079-124-20.  Recall #D-278-9.
CODE
Lot #8V938.
MANUFACTURER
Lederle Pharmaceutical, Division of American Cyanamid, Pearl 
River, New York.
RECALLED BY
UDL Laboratories, Inc., Rockford, Illinois (repacker), by letter 
dated June 14, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
3,624 unit cartons were distributed; firm estimated that 25 
percent of the product remained on market at time of recall 
initiation.
REASON
Mislabeling - Some blister strips are held in shelf unit cartons 
(100's) labeled as Allopurinol Tablets, 300 mg.  The blister 
strips are correctly labeled.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-950/951-9.
CODE
Unit #22394-5190.
MANUFACTURER
United Blood Services, Las Vegas, Nevada.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on 
September 24, 1997, and by letter dated October 14, 1997.  
Firm-initiated recall complete.
DISTRIBUTION
Nevada and Florida.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who traveled to an 
area considered endemic for malaria.
_______
PRODUCT
Red Blood Cells.  Recall #B-952-9.
CODE
Unit #G48051.
MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY
Manufacturer, by letter dated November 12, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Iowa.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who traveled to an area 
considered endemic for malaria.
________
PRODUCT
Red Blood Cells.  Recall #B-955-9.
CODE
Unit #J30422.
MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY
Manufacturer, by telephone on March 30, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Iowa.
QUANTITY
1 unit was distributed.
REASON
Blood product may have been contaminated during collection.
________
PRODUCT
Fresh Frozen Plasma.  Recall #B-959-9.
CODE
Unit numbers: 97FP07383, 97FP07384, 97FP10001, 97FP14576, 
98FP06068.
MANUFACTURER
Barnes-Jewish Hospital, St. Louis, Missouri.
RECALLED BY
Manufacturer, by telephone on March 8 and 9, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Missouri.
QUANTITY
5 units were distributed.
REASON
Blood products were labeled with extended expiration dates.
________
PRODUCT
a) Red Blood Cells; b) Cryoprecipitated AHF;
c) Recovered Plasma.  Recall #B-960/962-9.
CODE
Unit #16E21232.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, by letter dated February 3, 1999, or by fax on 
February 4, 1999.  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 IV 
drug use and sex with another male.
________
PRODUCT
Platelets, Pheresis.  Recall #B-978-9.
CODE
Unit #1079003.
MANUFACTURER
Community Blood Center, Dayton, Ohio.
RECALLED BY
Manufacturer, by letter dated March 26, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who received body 
piercing within 12 months of donation.
________
PRODUCT
a) Red Blood Cells; b) Rd Blood Cells, Leukocytes Removed; 
c) Platelets; d) Recovered Plasma.  Recall #B-979/982-9.
CODE
Unit Numbers: a)7618516, 7626780; b) 6790116; 
c) 6790116, 7626780; d) 7618516, 7626780, 6790116.
MANUFACTURER
New York Blood Services (Center West), New York, New York.
RECALLED BY
New York Blood Center, Inc., New York, New York, by letter dated 
September 8, 1998.  Firm-initiated recall complete.
DISTRIBUTION
New York and Switzerland.
QUANTITY
a) 2 units; b) 1 unit; c) 2 units; d) 3 units were distributed.
REASON
Blood products initially tested negative for the Human 
Immunodeficiency virus type 1 (HIV-1) p24 antigen, but 
retrospectively tested repeatedly reactive for HIV-p24, with an 
indeterminate neutralization test.
________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced.  Recall #B-994-9.
CODE
Unit 2615058.
MANUFACTURER
LifeSource, Glenview, Illinois.
RECALLED BY
Manufacturer, by telephone on February 22, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit was distributed.
REASON
Blood product was mislabeled as CMV antibody negative.
________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced.  Recall #B-995-9.
CODE
Unit #3704721.
MANUFACTURER
LifeSource, Glenview, Illinois.
RECALLED BY
Manufacturer, by telephone on December 10, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit was distributed.
REASON
Blood product had an unacceptable platelet count.
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-996/997-9.
CODE
Unit #H58725.
MANUFACTURER
Northern Illinois Blood Bank, Rockford, Illinois.
RECALLED BY
Manufacturer, by telephone on May 10, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who was not asked some 
of the pre-donation donor screening questions.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-1000/1002-9.
CODE
Unit #4040769.
MANUFACTURER
Community Blood Center, Dayton, Ohio.
RECALLED BY
Manufacturer, by letter dated December 21, 1998, or by fax 
December 11, 1998.  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 
cancer.
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall B-1004/1005-9.
CODE
Unit numbers: a) R44246, Q40911, Q23635, N97120; b) N97120.
MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY
Manufacturer, by letter dated June 3, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois and Indiana.
QUANTITY
a) 4 units; b) 1 unit.
REASON
Blood products tested negative for the antibody to the human 
immunodeficiency virus type 1 (anti-HIV-1), but were collected 
from a donor who previously tested repeatedly reactive for 
anti-HIV-1, Western blot negative.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Red Blood Cells.  Recall #B-953-9.
CODE
Unit numbers:  G47075 and G47063.
MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY
Manufacturer, by telephone on August 8, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
2 units were distributed.
REASON
Blood products were labeled with extended expiration dates.
________
PRODUCT
Red Blood Cells.  Recall #B-954-9.
CODE
Unit #J31022.
MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY
Manufacturer, by telephone on July 1, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit was distributed.
REASON
Blood product was leukoreduced by filtration greater than seven 
days after collection.
________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced
c) Platelets; d) Cryoprecipitated AHF; e) Recovered Plasma.  
Recall #B-983/987-9.
CODE
Unit Numbers:  a) 6713858, 6718452, 6719429, 6744732, 6746804, 
6750903, 6755303, 6765586, 6765601, 6794047, 6794086, 7437572, 
7439592, 7609342, 7621867, 7625339, 7677780, 6755780, 6794110
b) 6735701, 6716238
c) 6744732, 6746804, 7437572, 7609342, 7621867, 6735701
d) 6713858, 6718452
e) 6713858, 6718452, 6719429, 6744732, 6746804, 6750903, 6755303, 
6765586, 6765601, 6794047, 6794086, 7437572, 7439592, 7609342, 
7621867, 7625339, 7677780, 6755780, 6794110, 6735701, 6716238.
MANUFACTURER
New York Blood Services (Center West), New York, New York.
RECALLED BY
Manufacturer, by letter dated September 8, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
New York, New Jersey, Switzerland.
QUANTITY
a) 19 units; b) 2 units; c) 6 units; d) 2 units; e) 21 units were 
distributed.
REASON
Blood products initially tested negative for the antibody to the 
Human T-Lymphotropic virus type I (anti-HTLV-I), but 
retrospectively tested repeatedly reactive for anti-HTLV-I/II, 
PCR negative.
________
PRODUCT
Red Blood Cells.  Recall #B-1008-9.
CODE
Unit numbers: 55FH21721, 55FH21726, 55H66471, 55S94938, 55S94943, 
55S94945, 55S94951, 55S94952, 55S94956, 55S94960.
MANUFACTURER
American Red Cross Blood Services, Little Rock, Arkansas.
RECALLED BY
Manufacturer, by telephone on April 30, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Arkansas.
QUANTITY
10 units were distributed.
REASON
Blood products were returned after receipt at an unacceptable 
temperature and were redistributed.
________
PRODUCT
Red Blood Cells.  Recall #B-1009-9.
CODE
Unit #5090829.
MANUFACTURER
BloodCare, Dallas, Texas.
RECALLED BY
Manufacturer, by letter dated January 25, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor whose hemoglobin results 
were not documented during screening.
________
PRODUCT
Platelets, Pheresis.  Recall #B-1010-9.
CODE
Unit #1006615.
MANUFACTURER
Community Blood Center, Dayton, Ohio.
RECALLED BY
Manufacturer, by telephone on October 21, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was positive for Propionibacterium acnes.
________
PRODUCT
Red Blood Cells; b) Recovered Plasma.  
Recall #B-1011/1012-9.
CODE
Unit #5071236.
MANUFACTURER
BloodCare, Dallas, Texas.
RECALLED BY
Manufacturer, a) by telephone and letter on December 14, 1998, 
followed by second letter dated January 28, 1999; b) by letter 
dated December 14, 1998, followed by second letter dated March 
23, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Texas and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor whose arm inspection 
was not documented.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
________
PRODUCT
Bubble Suction Tubing, Catalog #116740.  Recall #Z-685-9.
CODE
Lot #41AJCM16 EXP 2004-01.
MANUFACTURER
ConMed Corporation, El Paso, Texas.
RECALLED BY
Manufacturer, by fax on February 19, 1999, and by letter dated 
February 22, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Florida and North Carolina.
QUANTITY
12 cases (50 units per case) were distributed.
REASON
Non-Sterility.
________
PRODUCT
Venturi Ventilators With CRT Monitor Part Number 1248.
Recall #Z-1038-9.
CODE
Serial numbers:  970129-970194 (not inclusive).
MANUFACTURER
MICROVITECH, United Kingdom (manufacturer of CRT).
RECALLED BY
Cardiopulmonary Corporation, Milford, Connecticut, by overnight 
mail on June 14, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Russia, United Kingdom, Italy.
QUANTITY
43 units were distributed.
REASON
CRT monitor does not meet the mean-time-between-failure (MTBF) 
specification.  The failure may result in the CRT  not displaying 
the monitored patient data.
________
PRODUCT
Venturi Ventilator with Hard Drive Part Number 230012.
Recall #Z-1039-9.
CODE
Serial numbers:  970129-980258 (not inclusive).
MANUFACTURER
Cardiopulmonary Corporation, Milford, Connecticut (ventilator); 
Segate, San Jose, California (hard drive).
RECALLED BY
Cardiopulmonary Corporation, Milford, Connecticut, by letter 
between June 14-15, 1999.  Firm-initiated field correction 
ongoing.
DISTRIBUTION
Alabama, Connecticut, Florida, North Carolina, Italy, Russia, 
United Kingdom.
QUANTITY
59 units were distributed.
REASON
User interface software will not load when unit is first powered 
on.
________
PRODUCT
GE Millennium MPR/MPS Single Detector Nuclear Medicine System 
(Emission Computed Tomography System), Model 2151300.  
Recall #Z-1068-9.
CODE
All units.
MANUFACTURER
General Electric Medical System, Waukesha, Wisconsin.
RECALLED BY
Manufacturer, by safety notice dated June 10, 1998.  
Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
167 units were distributed.
REASON
An unintended detector tilt motion can occur when the operator 
selects the table up/down motion.
________
PRODUCT
Bone-Dri Femoral Surgical Wick, used to control and wick fluids 
from the femoral canal during surgery. 
Recall #Z-1069-9 
CODE
Catalog Numbers: 6209-1-205 (package of 5 units)
                 6209-1-201 (single unit)
Sterility Lot Codes: 9902144, 9902145, 9902146, 9902147, 9902203, 
9902204, 9902501, 9902542, 9902543, 9902544, 9902545, 9902744, 
9902747, 9902748, 9902845, 9902846, 9902847, 9902848, 9902849, 
9902852.
MANUFACTURER
Howmedica Osteonics Corporation, San Jose, California.
RECALLED BY
Manufacturer, by letter dated February 17, 1999, followed by 
telephone.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
178 units were distributed.
REASON
The sterility of the device has been compromised due to a lack of 
adequate sterilization.
________
PRODUCT
King Systems brand Universal F2 Breathing Circuits with 
Co-Axial Filter. Recall #Z-1077-9.
CODE
Various product numbers and lot numbers.
MANUFACTURER
King Systems Corporation, Noblesville, Indiana.
RECALLED BY
Manufacturer, by letter dated February 23, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
4,531 cases (101,580 breathing circuits) were distributed.
REASON
Excessive flash in the filter housing may significantly increase 
resistance to flow in the expiratory side of the unit.
________
PRODUCT
CryoValve Allograft (heart valve): a) Model AV00;
b) PV00.  Recall #Z-1078/1079-9.
CODE
Serial Numbers:  a) 6280773; b) 6280765. Donor #32029
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter sent on June 21, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Canada.
QUANTITY
2 units.
REASON
Donors do not meet current guidelines regarding serodilution of 
plasma because of the amount of transfused/infused fluids 
administered.
________
PRODUCT
CryoValve Allograft (heart valve) Model PV00. 
Recall #Z-1080-9.
CODE
Serial #3864863. Donor #19913.
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter sent on June 21, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Oklahoma.
QUANTITY
1 unit.
REASON
Donors do not meet current guidelines regarding serodilution of 
plasma because of the amount of transfused/infused fluids 
administered.
________
PRODUCT
CryoValve Allograft (heart valve), Model AV00.
Recall #Z-1081-9.
CODE
Serial #3864855.
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter dated June 18, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Idaho.
QUANTITY
1 unit.
REASON
Donors do not meet current guidelines regarding serodilution of 
plasma because of the amount of transfused/infused fluids 
administered.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
Connecting screw and compression screw for titanium solid humeral 
nails, Part Numbers: 358.54 and 358.61.
Recall #Z-1066/1067-9.
CODE
Part Number  358.54, Lot Numbers: A4FL336, A4GA308, A4GC384, 
A4GC813, A4HB049, A4HB716, A4HD872, and A4HD873; Part Number 
358.61, Lot numbers: A4GA932, A4GA933, A4GC425, A4GD662, 
A4GE889, and A4GK100.
MANUFACTURER
Synthes (USA), West Chester, Pennsylvania.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter sent on June 16, 
1999, followed by telephone or visit.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
339 units were distributed.
REASON
Product drawing contained an interference issue which created a 
potential for the connecting screw not to fit into or bind within 
the insertion handle.
________
PRODUCT
DePuy Self-Centering Hip Cups:
a) Size 22.225 mm, Product No. 1035-44-000;
b) Size 28 mm, Product No. 1037-45-000.  
Recall #Z-1082/1083-9.
CODE
Lot numbers: a) S73LR1; b) S74DC1.
MANUFACTURER
DePuy Orthopaedics, Inc., Warsaw, Indiana.
RECALLED BY
Manufacturer, by verbal notification on March 24, 1999, and by 
letter dated March 25, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Missouri, New Jersey, Pennsylvania, Canada, England, Japan.
QUANTITY
2 lots of 10 units each were distributed.
REASON
Labeling mix-up -- A 28 mm cup was found in a carton labeled as a 
22.225 mm cup, and a  22.225 mm cup in a carton labeled as a 28 
mm cup.
________
PRODUCT
Bivona Fome-Cuf Pediatric Tracheostomy Tube with Stomaseal, 
Catalog No. 85P045.  Recall #Z-1084-9.
CODE
Lot No. 842260 EXP 03/2004.
MANUFACTURER
Bivona Medical Tech., Division of UroQuest Med. Corporation, 
Gary, Indiana.
RECALLED BY
Manufacturer, by letter sent on June 15, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Arizona, Florida, Michigan, New Hampshire, Texas, Virginia, 
Australia.
QUANTITY
21 units were distributed.
REASON
The tube's outer shaft diameter printed on the neckflange of the 
tube differed from that on the label.

END OF ENFORCEMENT REPORT FOR JULY 21, 1999.


####