ENFORCEMENT REPORT FOR
...REASON The product contains undeclared egg whites, snow crabmeat, pollock, and wheat.....Valve Product Number Lot Number Number of Lots Range BLD-9007-477 10 816065/909003 BLD.....Valve Product Number Lot Number Number of Lots Range BLD-8897 2 833054/903054 BLD-8898 3..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00612.html (score=100)

Premarket Approval Decisions for November 2001
...Approval for a change in the Final Product Shipping Medium including the replacement of.....The Hall Easy-Fit™ Prosthetic heart Valve is a modification of the approved Medtronic Hall.....The supplement requested approval of this size as an addition to the existing, approved..
http://www.fda.gov/cdrh/pma/pmanov01.html (score=40)

Premarket Approval Decisions April 1999
...Approval for changing the name of the product form Gelfoam Sterile Powder to Gelfoam.....Approval for the addition of 35mm and 37mm mitral valve sizes to the SJM® Master Series.....The 30-Day Notice requested that "end-product" pyrogen testing be performed on non-sterile..
http://www.fda.gov/cdrh/pma/pmaapr99.html (score=40)

MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....drug substance, optimized formulation, valve and actuator design, 89.. manufacturing.....program because they can affect the ability of the product to deliver reproducible doses..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=13)

Guidance for Industry
...valve assembly, the acceptability of the valve packing and the valve seal used, the type.....usually contain a residual product and a commingling of new and old product would result.....would examine whether any of the threads on the valve or on top of the valve stem are..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=13)

GUIDE TO INSPECTIONS OF LYOPHILIZATION OF PARENTERALS
...The free water in a product is that water that is absorbed on the surfaces of the product.....When this valve is closed the chamber is isolated from the external condenser. Also known.....Lyophilization or freeze drying is a process in which water is removed from a product..
http://www.fda.gov/ora/inspect_ref/igs/lyophi.html (score=13)

FDA Enforcement Report
...This failure to unseal can result in the failure of the valve to properly flush air prior.....Product manufactured without heat treatment using cream contaminated with Listeria.....Pressure exceeding the recommended maximum of 25 psi may result in the small tubing valve..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00004.html (score=13)

FDA Enforcement Report
...The erythromycin/sulfisosoxazole product is mislabeled as the one ingredient erythromycin.....One of the two leaflets of the valve may fracture and break loose from the valve housing.....Blood product, labeled with incorrect expiration date due to the addition of AS-1 additive..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00119.html (score=13)

ENFORCEMENT REPORT FOR MAY 12, 1999
...REASON The valve has the potential to separate from the Argon tank because it does not fit.....CODE All product codes produced and distributed between September 22, 1998 and February 8.....REASON The device may give erroneous results because of the valve gasket deterioration in..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00589.html (score=13)

ENFORCEMENT REPORT FOR MARCH 29, 2000
...Jude Medical Masters Series Rotatable Aortic Mechanical Heart Valve with Silzone Coating.....REASON Blood product was collected from a donor who reported travel to an area designated.....Jude Medical Masters Series Rotatable Mitral Mechanical Heart Valve with Silzone Coating..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00635.html (score=13)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...This would include any problems associated with the drug product, the valve, the high pressure cylinder.....problems associated with the valve, the valve seal material, ejection of valve stems, the container.....However, an odor test may be performed on a vaporized sample of the liquid product obtained through the product..
http://www.fda.gov/cder/dmpq/freshair.htm (score=13)

FDA Enforcement Report For November 4, 1998
...Blood product was collected from a donor who had no hemoglobin/hematocrit check recorded.....Code 31679 - 16FR Suction Catheter with SAFE-T-VAC VALVE, 2 Walleted Latex Gloves, pop-up.....586 boxes were distributed; firm estimated that 50 percent of the product remained on..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00562.html (score=13)

FDA Enforcement Report
...Product uses a piggyback feature in which the rubber check back valve may become tilted.....V7215 15 Drops/mL Intelligent Pump Measured Volume Primary Additive Set with Check Valve.....Blood product collected from a donor who was subsequently diagnosed as having a gum..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00016.html (score=13)

FDA Enforcement Report
...PRODUCT Vita-Min 75 Extra High Potency Multiple Vitamins with chelated minerals, product.....CODE Various catalog and serial numbers, but all contain a 3-Way Bypass Valve (p/n 860003.....PRODUCT Sonoline SI-450D Ultrasound Imaging System with Version 1.1.5 Software Installed..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00394.html (score=13)

Compressed Medical Gases Guideline, 2/89 (cmgg89.htm)
...The court-enforced actions include seizure of finished product, bulk product, ingredients, and equipment.....The manifolds are equipped with fill connections that correspond only to the container.....The use of manifold and container valve connections recommended in the Compressed Gas..
http://www.fda.gov/cder/guidance/cmgg89.htm (score=13)

ENFORCEMENT REPORT FOR 07/21/99
...PRODUCT Trihexyphenidyl Hydrochloride Tablets, 5 mg, in 100 tablet blister strips of 10.....REASON Blood product was collected from a donor who traveled to an area considered endemic.....REASON Blood product was collected from a donor who received body piercing within 12..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00599.html (score=13)

FDA Enforcement Report
...PRODUCT Corometrics 116 Fetal Monitor, intended to monitor heart rate and uterine activity.....PRODUCT ECG Lead Sets and Electrodes used in specific Vista and Vista HPQ Models 0.5T, 1.....valve (Part #0103-07-0001) due to premature aging of the valve, which can lead to reduced..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00165.html (score=13)

FDA Enforcement Report
...Saline-Filled Oval Mammary Prosthesis with Posterior Mentor Leaf Valve Fill Tube, used for.....The product is contaminated with the pesticide chlorothalonil in excess of prescribed.....Blood product which tested non-reactive for the antibody to the Human Immunodeficiency..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00015.html (score=13)

FDA Enforcement Report
...PRODUCT Kennedy Gourmet Honey, Lemon and Mint Flavored Tea-Sickles, tea spoons with.....Emergency Portable Unit-Model 477-27-6; Filled aluminum cylinders with Erie Post valve 870.....PRODUCT Rising Sun Farm brand Salad Vinaigrette and marinades in 12.5 fluid ounce glass..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00407.html (score=13)

FDA Enforcement Report
...PRODUCT Nezhat-Dorsey SmokEvac Trumpet Valve for Pump II, a laparoscopic suction/irrigation system with metered smoke evacuation.....PRODUCT Sterile Triamcinolone Diacetate Suspension, USP, 40 mg/ml, injectable Rx drug for.....2027P2; (b) Nezhat-Dorsey SmokEvac Trumpet Valve and Pump II Cartridge and 33 cm Probe Tip..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00429.html (score=13)

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