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Abbott Laboratories HPD/ADD/GPRD: AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one ...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Abbott Laboratories HPD/ADD/GPRD: IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL bottle...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Baxter Healthcare Corp. Rt: Micromix BCR Compounder, product code 2M8297; a pharmacy ...

The compounder may omit an ingredient during the compounding process.

FDADec 16, 2003UT, WI• Baxter Healthcare Corp. Rt

Roche Diagnostics Corp.: Roche brand OMNI 8 clinical chemistry analyzer; catalog n...

If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.

FDADec 15, 2003Nationwide• Roche Diagnostics Corp.

Abbott Laboratories HPD/ADD/GPRD: ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit ...

The calibrator lots may yield Free T4 values that are depressed.

FDADec 15, 2003Nationwide• Abbott Laboratories HPD/ADD/GPRD

Roche Diagnostics Corp.: Roche brand OMNI 7 clinical chemistry analyzer; catalog n...

If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.

FDADec 15, 2003Nationwide• Roche Diagnostics Corp.

Rocking Chairs (Unbranded) – Structural Weakness (2003)

The wooden rocking chairs were sold in two styles, a contemporary model (PI155131) and a more traditional model (P155132). Both style rocking chairs have a clear varnish finish. The rocking chairs can be identified by washers and screws located under the seat, near the legs.

CPSCDec 15, 2003Nationwide

Invacare Corporation: Invacare 2G Tarsys Seating System, Model 2GT.

The weld joints on the seat back may fail and cause possible injury to the patient.

FDADec 15, 2003Nationwide• Invacare Corporation

Becton Dickinson & Co.: Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, cont...

Diagnostic test kit may exhibit false positive results.

FDADec 15, 2003Nationwide• Becton Dickinson & Co.

Roche Diagnostics Corp.: Roche brand OMNI 9 clinical chemistry analyzer; catalog n...

If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.

FDADec 15, 2003Nationwide• Roche Diagnostics Corp.

Smiths Medical ASD, Inc.: PER-FIT Percutaneous Dilational Tracheostomy Kit with Spe...

Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm

FDADec 12, 2003AZ, CA, CO +10 more• Smiths Medical ASD, Inc.

Zutopia Girls' Loungewear – Fabric Safety Concern (2003)

The 15 different styles of loungewear involved in this recall are available in girl's sizes small through extra-large (equivalent to girl's sizes 7-14). The following items are involved in the recall and are labeled "Zutopia": Style No.TypeDescriptionPriceR/N# 3254 Two-piece, camisole and capri pant Blue with "Stick with me, my dreams come true" on the Camisole and on the Capri $26.50 106503 3256 Two-piece, tank and capri pant set White and light blue with "Angel's Car-Hop" on the tank $26.50 106503 S3258 Two-piece, camisole and short set White and navy with "Funky Monkey" on the camisole $18.50 106503 3252 Two-piece, tank and capri pant set Red with "Chit-Chat Telephone Co." on the tank $26.50 106503 3255 Two-piece, camisole and capri pant set Red and white with "Your Lips keep moving… but all I hear is 'Blah, Blah, Blah' " on the camisole and "Blah, Blah, Blah" on the capri pant $26.50 106503 3261 Two-piece, camisole and short set White and pink with "DJ Scratchy Itchy" on the camisole and hearts and notes on the short $18.50 106503 3262 Two-piece, camisole and capri pant set White and pink with "Sparky's Bowling and Rolling Rink…" on the camisole $26.50 106503 3257 Two-piece, camisole and capri pant set Multi-colored set with "Cutie" on the camisole $26.50 106503 3267 Capri pant Light blue with pink poodles and polka dots $19.50 106503 33340722 Lounge pant Black or red with "It's All About Me. david and goliath" $24.50 78749 33106182 Lounge pant White with "Chick's Rule, david and goliath" and a caricature of a chick screened on the pant $24.50 78749 33340685 Lounge pant Blue with "Boys are Smelly, david and goliath" on the pant along with a caricature of a boy. $24.50 78749 33105727 Lounge pant Pink with "Boys are stupid, throw rocks at them!" On the pant along with a caricature of a boy. $24.50 78749 32771848 Capri pant Hawaiian print capri pant in blue and pastel colors with palm trees and flowers $18.00 106503 32771893 Capri pant Hawaiian print capri pant in pink and pastel colors with palm trees and flowers $18.00 106503

CPSCDec 12, 2003Nationwide

Snow House Candles (Home Trends) – Flammable Paint (2003)

Each Home Trends Ice Holiday Collection Candle gift set contains three candles with one of these scenes painted on the exterior: Snow House Winter; Snowman; or Snowflake design.

CPSCDec 12, 2003Nationwide• Qingdao Kingking Applied Chemistry Co., Ltd., China

Jack-In-the-Box Toys (Schylling) – Mechanical Issue (2003)

Two designs of the "Jack-In-the-Box" type toys are included in this recall, both of which play "Pop Goes the Weasel" when the crank is turned. One is based on Dr. Seuss' "Cat in the Hat", and the other is based on Ian Falconer's "Olivia the Pig" character. The Cat in the Hat box is red, yellow and blue and has a black and white cat dressed in a red and white hat that pops out of the box. "CAT IN THE HAT" is written on the box lid. The Olivia box is black- and salmon-colored with "CIRCUS" written around the top sides. The Olivia character dressed as clown pops out. Schylling Associates Inc. previously recalled a Bear "Jack-In-the-Box" type toy in November with the same hazard.

CPSCDec 12, 2003Nationwide• Schylling Associates Inc., of Rowley, Mass.

Arctic Cat Snowmobiles – Ski Defect (2003)

The recalled red plastic skis (part number 1703-131) were used on a number of 2003 Arctic Cat Firecat models. All 2003 Arctic Cat Firecat snowmobiles produced with red plastic skis are included in this recall.

CPSCDec 12, 2003Nationwide• Arctic Cat Inc., of Thief River Falls, Minn.

Flutterby Plush Toys (First & Main) – Accessory Hazard (2003)

This Flutterby plush toy is a winged horse. These pink, blue or purple toys have small plastic gem stones attached to the horse's wings. The toys have labels reading, "First & Main, Inc., Lombard, IL, Flutterby, Item No. 4005."

CPSCDec 12, 2003Nationwide• First & Main Inc., of Lombard, Ill.

Cardinal Health: Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each...

The product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed.

FDADec 11, 2003IN, OH, PA• Cardinal Health

Depuy Orthopaedics, Inc.: Depuy brand ACE trochanteric nail; sterile, long, left hi...

The lag screw may migrate to the femoral head or into the abdominal cavity.

FDADec 11, 2003Nationwide• Depuy Orthopaedics, Inc.

Urologix, Inc.: Prostatron Praktis Type II for Transurethral Microwave Th...

During treatments, using the Prostatron units, the devices' Temperature Sensing System may change the rectal temperature reading by up to 2 degrees Celsius and may briefly delay updates to the rectal temperature reading.

FDADec 10, 2003Nationwide• Urologix, Inc.

Cryolife Inc: CryoValve Pulmonary Valve and Conduit

As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

FDADec 10, 2003IN, TX• Cryolife Inc

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