FDA

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.

October 30, 2002
02-43

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

_____________________________
PRODUCT
Mini Fruit Jellies, all flavors, in sizes 53 oz. jars; 10.5 oz. poly bags. Brand name is "JoeLee" where the "o" is a happy face.
a) Mango Flavor. Recall # F-016-3;
b) Lychee Flavor. Recall # F-017-3;
c) Assorted Flavor. Recall # F-018-3;
d) Grape Flavor. Recall # F-019-3;
e) Strawberry Flavor. Recall # F-020-3;
f) Peach Flavor. Recall # F-021-3;
g) Pineapple Flavor. Recall # F-022-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Joaly Enterprise Company, La Mirada, CA, by press release and letters on January 7, 2002.
Manufacturer: Jojomo Enterprise Co. Ltd., Chang-Hua, Taiwan. Firm initiated recall is ongoing.
REASON
This type of candy is in violation of section 402 (a)(3) of the Federal Food, Drug, and Cosmetic Act in that it is unfit for food due to the characteristics that result in a serious choking hazard.
VOLUME OF PRODUCT IN COMMERCE
138,804 cases in 2001.
DISTRIBUTION
AZ, CA, FL, NC, NV, NY and TX.

_____________________________
PRODUCT
Mini Gel Candies. The candies were sold under the brand names New Choice Mini Fruit Gels, Yummy Choice Fruit Gel Snacks, and Sheng Hsiang Jen (chinese label) Conjac Coconut jell. The products were sold in the following flavors:
a) Apples. Recall # F-023-3;
b) Grape. Recall # F-024-3;
c) Taro. Recall # F-025-3;
d) Lychee. Recall # F-026-3;
e) Peach. Recall # F-027-3;
f) Pineapple. Recall # F-028-3;
g) Mango. Recall # F-029-3;
h) Orange. Recall # F-030-3;
i) Lemon. Recall # F-031-3;
j) Strawberry. Recall # F-032-3;
k) Assorted. Recall # F-033-3.
The candies were sold in bags containing 18 units per bag and shipped 30 bags per case. The candies were also sold in plastic jars containing 88 units per jar and shipped 6 jars per case.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Santi and Sons, Reading, PA., by press release on July 23, 2002 followed by visit.
Manufacturer: Sheng Hsiang Jen Foods Co. Ltd, Taiwan, Republic of China. FDA initiated recall is complete.
REASON
This type of candy is in violation of section 402 (a)(3) of the Federal Food, Drug, and Cosmetic Act in that it is unfit for food due to the characteristics that result in a serious choking hazard.
VOLUME OF PRODUCT IN COMMERCE
1642296 individual units.
DISTRIBUTION
PA and DE.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

_____________________________
PRODUCT
Luokeng Fresh Bamboo Shoot packaged in a vacuum packed, flexible plastic bag, net wt. 17.05 ozs. Recall # F-013-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ADCO (USA) Inc., Brooklyn, NY, by letter dated October 2, 2001.
Manufacturer: Xinhui Foodstuffs Co., Xinhui City, China.
State initiated recall is complete.
REASON
The product appears to be a low-acid food capable of supporting growth of C. botulinum.
VOLUME OF PRODUCT IN COMMERCE
26 cases (30 - 17.5 oz. packages per case).
DISTRIBUTION
NY.

_____________________________
PRODUCT
Alaska Supreme brand ice cream in 1/2 gallon containers.
Flavors include:
a) Base Camp Coffee. Recall # F-034-3;
b) Chocolate. Recall # F-035-3.
CODE
All codes up to MAY 16 2003.
RECALLING FIRM/MANUFACTURER
Alaska Supreme Ice Cream Co., Anchorage, AK, by visit beginning August 19, 2002. FDA initiated recall is complete.
REASON
The products contained the undeclared color FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE
Approx. 52 gallons.
DISTRIBUTION
AK.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

_____________________________
PRODUCT
Apple juice labeled in part "Minute Maid APPLE JUICE***16 FL OZ*** PASTEURIZED***MANUFACTURED UNDER THE AUTHORITY OF THE MINUTE MAID COMPANY A DIVISION OF THE COCA-COLA COMPANY, HOUSTON, TX 77252". Packaged in 16-oz plastic bottles 24 per case. Recall # F-014-3.
CODE
Product labeled with code JAN1303WTB2CAL
x (x=Military Times ranging from 1800-0105).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Minute Maid Company, Houston, TX, by letter on March 15, 2002.
Manufacturer: Minute Maid, Waco, TX. Firm initiated recall is complete.
REASON
Apple juice contains mold.
VOLUME OF PRODUCT IN COMMERCE
24,695 cases.
DISTRIBUTION
NM, TX, LA, AZ and OK.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_____________________________
PRODUCT
Fluocinonide Cream USP, 0.05%, Rx only, 15g (0.53oz), 30g (1.1oz), and 60g (2.2oz) tubes. Recall # D-029-3.
CODE
Lot#: L106046, L106047, L106048, L108101, L108102, L108103, L110094, L110095, L110096, L202079.
RECALLING FIRM/MANUFACTURER
Alpharma Uspd, Inc., Lincolnton, NC, by letters on September 30, 2002. Firm initiated recall is ongoing.
REASON
Product exceeded specification for degradant level (18 month stability).
VOLUME OF PRODUCT IN COMMERCE
63852 units, various sizes.
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
Select Brand®, Night-Time Adult Cold Medicine, Original Flavor, 6 FL. OZ. (177 mL), clear plastic triangular bottle. Recall # D-036-3.
CODE
051L1C, Exp 12/04.
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, Inc., Huntsville, AL, by letter dated August 20, 2002. Firm initiated recall is ongoing.
REASON
Subpotent for one active ingredient-pseudoephedrine hydrochloride-by manufacturer (6 month stability).
VOLUME OF PRODUCT IN COMMERCE
35,963 bottles.
DISTRIBUTION
AK.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0066-3.
CODE
Unit number KC00846.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated April 24, 2002.
Manufacturer: Tri-Counties Blood Bank, Santa Barbara, CA.
Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0067-3.
CODE
Unit number 06GH67260.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern California Region, Los Angeles, CA, by letter dated February 15, 2002.
Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_____________________________
PRODUCT
Counterfeit Procrit_ (Epoetin alfa), labeled as 40000 unit/ml vials, 4 vials/box. Recall # B-0068-3.
CODE
Lot numbers P002641 and P002384.
RECALLING FIRM/MANUFACTURER
AmeriSourceBergen Corporation, Orange, CA, by letter on June 12, 2002. Firm initiated recall is complete.
REASON
Counterfeit drug product, with a concentration of active ingredient less than labeled, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 lots.
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0069-3;
b) Red Blood Cells, Leukocytes Reduced Irradiated. Recall
B-0070-3.
CODE
a) Unit number 0664309;
b) Unit number 0664306.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, Irwin Center, San Francisco, CA., by letter dated August 13, 2001.
Manufacturer: Blood Centers of the Pacific, Peninsula/South Bay Center, Burlingame, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose hemoglobin test was incorrectly documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0072-3;
b) Cryoprecipitated AHF. Recall # B-0073-3.
CODE
a) and b) Unit number FJ93945.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on June 18, 2002.
Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
RI.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0074-3;
b) Recovered Plasma, Recall # B-0075-3.
CODE
a) and b) Unit number 04KK60295.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letters on July 22, 2002 and August 15, 2002. Firm initiated recall complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VT and CA.

_____________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0076-3
CODE
Unit LX00037.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on December 27, 2001.
Manufacturer: Tri-Counties Blood Bank, Santa Barbara, CA.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor on Coumadin therapy, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0065-3.
CODE
Units 29GW35656, 29GW35253.
RECALLING FIRM/MANUFACTURER
American Red Cross, Mid-Atlantic Regional Blood Services, Norfolk, VA, by letters dated April 22 and May 22, 2002.
Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD.

_____________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0071-3
CODE
Unit numbers 0664309 and 0664306.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter dated August 13, 2001.
Manufacturer: Blood Centers of the Pacific, Peninsula/South Bay Center, Burlingame, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose hemoglobin test was incorrectly documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0079-3;
b) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0080-3.
CODE
a) Unit numbers 012L70114 and 012L70118;
b) Unit numbers 012GW22709, 012GW22710, 012GW22711,
012GW22712, 012GW22714 (distributed as two split units),
012GW22716, 012GW22717, 012GW22718, 012GW22719
(distributed as two split units), 012GW22720,
012GW22721, and 012GW22722.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on June 24 and 25, 2002 and by letter dated July 5, 2002. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for antibodies to hepatitis C virus (anti-HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
MO, NC and TN.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_____________________________
PRODUCT
Aesculap Ti Bone Screws, 4x56 mm. Recall # Z-0116-3.
CODE
Lot number 5634922.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aesculap, Inc., Center Valley, PA, by letters dated June 14, 2002.
Manufacturer: Aesculap Ag & Co. Kg. Tuttlingen, Donau, Germany. Firm initiated recall is complete.
REASON
Smaller than specified core diameter may lead to screw breakage during and post-implantation.
VOLUME OF PRODUCT IN COMMERCE
55 units.
DISTRIBUTION
FL, NJ, and UT.

_____________________________
PRODUCT
a) Meridian Medical Systems (MMS) brand Wye-Swivel, Plain;
Part/Model Number 020104347. Recall # Z-0121-3;
b) Meridian Medical Systems (MMS) brand Wye-Swivel, GSP;
Part/Model Number 020104348. Recall # Z-0122-3.
CODE
a) Lots 347270402, 352940502, 355440502, 355630502,
357260502, 356960502, 35810602 and 357270502;
b) Lots 353390502, 356160502, 357290502 and 357280502.
RECALLING FIRM/MANUFACTURER
Meridian Medical Systems, Inc., Indianapolis, IN, by letter dated September 18, 2002. Firm initiated recall is complete.
REASON
Swivel leg may crack and leak at connection with the body.
VOLUME OF PRODUCT IN COMMERCE
138,600 wyes.
DISTRIBUTION
Costa Rica.

_____________________________
PRODUCT
Fabius GS Anesthesia Gas Machine. Recall # Z-0123-3.
CODE
Catalog number 4117110.
RECALLING FIRM/MANUFACTURER
Drager Medical, Telford, PA, by letter on August 14, 2002.
Firm initiated recall is ongoing.
REASON
Intermittent leaks associated with APL valve.
VOLUME OF PRODUCT IN COMMERCE
764 units.
DISTRIBUTION
Nationwide and Internationally.

_____________________________
PRODUCT
0.5cc 30G x 5/16 Walgreens brand syringes (cases of 5 boxes of 100 or boxes of 100 each)and .5cc 29GA x 1/2" (12.7mm) insulin syringe. Recall # Z-0125-3/Z-0126-3.
CODE
Catalog No.; Walgreens: 676987, BD's: 928854
Lot Codes:
8742; 8743; 8779; 8780; 8781; 8782; 8783;
8784; 8785; 8786; 8804; 8814; 8815; 8816.
Catalog No.: Walgreens: 677258, BD's 928851
Lot Codes:
8230; 8764; 8765; 8766; 8774; 8775; 8776;
8777; 8787; 8795; 8796; 8797; 8798; 8799;
8800; 8801; 8802; 8803; 8805; 8806; 8807;
8808; 8809; 8822.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letter on September 6, 2002 and October 3, 2002.
Manufacturer: Boin Medica Co. Inc., Kumi City, Kyungbuk, Korea. Firm initiated recall is ongoing.
REASON
Product has a recessed cannula which makes it difficult to remove the bubbles.
VOLUME OF PRODUCT IN COMMERCE
8,683,000 devices.
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
SynchroMed EL Implantable Infusion Pumps, Models 8626-10, 8626L-10, 8627-10, 8627L-10, 8626-18, 8626L-18, 8627-18, and 8627L-18. Recall # Z-0127-3/Z-0134-3.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Medtronic, Inc., Neurological Division, Minneapolis, MN, by letter dated September 2002. Firm initiated recall is ongoing.
REASON
Inadequate directions for use.
VOLUME OF PRODUCT IN COMMERCE
55,000 pumps (about 46,000 in the U.S. and 9,000 in foreign countries).
DISTRIBUTION
Nationwide and Internationally.

_____________________________
PRODUCT
SABRE Bioabsorbable Polymer Sling With Introducer, catalog numbers 93-1030 (1.0 cm x 3.0 cm sling) and 93-1575 (1.5 cm x 7.5 cm sling) and SABRE Introducer, catalog number 93-1000. Recall # Z-0135-3.
CODE
All lot numbers of catalog numbers 93-1000, 93-1030 and 93-1575, distributed prior to the recall, are affected.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mentor Minnesota Inc., Minneapolis, MN., by telephone on September 27 and 28, 2002 and by letter on September 27, 2002.
Manufacturer: Prosurg Inc., San Jose, CA. Firm initiated recall is ongoing.
REASON
Holes observed in the sterile packaging.
VOLUME OF PRODUCT IN COMMERCE
379 units.
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
Lorenz brand 99-7215-01 Low Profile Center Drive 1.5X15mm Titanium Screw. Sold one per package and 5 per package. Recall # Z-0136-3/Z-137-3.
CODE
Lot Numbers 206770, 163140, 132960, 113440, 113450, 098740.
RECALLING FIRM/MANUFACTURER
Walter Lorenz Surgical, Inc., Jacksonville, FL, by telephone on May 23, 2002 and by letter June 4 -7, 2002.
Firm initiated recall is complete.
REASON
Screws were not fully cleaned per current SOP's before distribution.
VOLUME OF PRODUCT IN COMMERCE
193.
DISTRIBUTION
Nationwide and Canada, Germany and Japan.

_____________________________
PRODUCT
Perry Baromedical Hyperbaric Chambers- SIGMA MP Multiplace Hyperbaric Oxygen Treatment Chambers. These prescription devices are used in hospitals and clinics to treat multiple patients at a time for conditions such as air or gas embolism, gas gangrene, necrotizing soft tissue infections and thermal burns. Recall # Z-0139-3.
CODE
All codes/serial numbers involved.
RECALLING FIRM/MANUFACTURER
Perry Baromedical Corporation, Riviera Beach, FL, by letter on June 11, 2001. FDA initiated recall is ongoing.
REASON
Change testing of Fire Suppression System to monthly.
VOLUME OF PRODUCT IN COMMERCE
18.
DISTRIBUTION
Nationwide and Canada.

_____________________________
PRODUCT
INTRALASE FS 600 C Laser System (Model 1), Laser Keratome. Recall # Z-0147-3.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
IntraLase Corporation, Irvine, CA, by letter dated October 2, 2002. FDA initiated recall is ongoing.
REASON
Design defect, wire breakage, causes laser failure, interrupting surgery.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
Nationwide and Mexico.

****CORRECTION****

The Enforcement report 02-42, for 10/23/02, Recall # Z-0110-03, Vistacon, one of the lot numbers was listed incorrectly. The Lot listed as "B000WJK(XXX )" should be listed as "Lot B000WJP (XXX )(-5.00D, 8.7 B.C.)".

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_____________________________
PRODUCT
Palco Laboratories brand Pulse Oximeter; Models: 100, 130, and Aero (non-medical pulse oximeter)
a) For Model 100 Product Number is: 1001010.
Recall # Z-0118-3;
b) For Model 130, Product Number is: 1001013.
Recall # Z-0119-3;
c) For AERO Model, Product Number is: 1001012.
Recall # Z-0120-3.
CODE
For Serial Numbers:
a) Serial Numbers are:
1270000001 to 1270000382 (may contain -01 at the end)
12700100001 to 12700100775;
b) Serial Numbers are:
1030000001 to 1030000055 (number may contain -01
at the end);
c) Serial Numbers are:
1260000001 to 1260000026 (number may contain -01
at the end)
12600100001 to 12600100045.
RECALLING FIRM/MANUFACTURER
Palco Laboratories, Inc., Santa Cruz, CA, by letters on August 27, 2002. Firm initiated recall is ongoing.
REASON
A capacitor was loaded backwards into the Pulse Oximeter.
VOLUME OF PRODUCT IN COMMERCE
1050 units.
DISTRIBUTION
Nationwide and Internationally.

_____________________________
PRODUCT
Access 2 Immunoassay Systems -- Systems Software
Versions 1.0; 1.1; 1.2; and 1.3.1. Recall # Z-0124-3.
CODE
Product Name: Access 2 Software
Part Number: 973074

Lot Number

Software Version

212702

1.3.1

212701

1.3.1

211403

1.3

210332

1.3

210331

1.3

108609

1.2

108104

1.2

107317

1.2

106682

1.2

106447

1.2

106146

1.1

105903

1.1

105270

1.1

104958

1.1

104485

1.1

103905

1.0

103436

1.0

103010

1.0.

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on June 12, 2002. Firm initiated recall is ongoing.
REASON
Erroneous result flags can result on printed reports and screen displays in rare circumstances.
VOLUME OF PRODUCT IN COMMERCE
442.
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
Vortex Port-LP Access System with Attachable Catheter. Recall # Z-0138-3.
CODE
REF P12155, LOT 981201, 2003-12 EXPIRATION DATE.
RECALLING FIRM/MANUFACTURER
Recallinf Firm: Horizon Medical Products, Inc., Manchester, GA, by visit in January 2001.
Manufacturer: Norfolk Medical Products, Inc., Skokie, IL.
Firm initiated recall is ongoing.
REASON
Mislabeling of Vortex Port-LP Access System with Attachable Catheter.
VOLUME OF PRODUCT IN COMMERCE
45 units.
DISTRIBUTION
AL, FL, IN, MK, NY, PA and TX.

_____________________________
PRODUCT
INTERLASE FS 600 C Laser System (Model 1), Laser Keratome. Recall # Z-0140-3.
CODE
All units.
RECALLING FIRM/MANUFACTURER
IntraLase Corp., Irvine, CA, by letters dated October 2, 2002. Firm initiated recall is ongoing.
REASON
Cooling system problem causes machine to become inoperable.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
Nationwide and Mexico.

_____________________________
PRODUCT
"FrameLock" device, Product Number 960-808, intended for intra-operative use with the LandmarX Image Guided Surgery System as a device to regidly mount a reference arc to a patient's skull. The product has an open cannula nut which is missing for the referenced lot number. The kit is packaged in a metal sterilization tray which is wrapped in plastic. Recall # Z-0146-3.
CODE
Lot 23353200.
RECALLING FIRM/MANUFACTURER
Xomed, Inc., Jacksonville, FL, by letter dated September 4, 2002. Firm initiated recall is ongoing.
REASON
Framelock assemblies packed with Open Cannula Nuts.
VOLUME OF PRODUCT IN COMMERCE
22.
DISTRIBUTION
Nationwide and France, the Netherlands and Japan.

END OF ENFORCEMENT REPORT FOR OCTOBER 30, 2002

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