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High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 ...
Surgical Devices·100 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: The Transpac Disposable Straight Pressure Transduc...
Surgical Devices·150 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transd...
Surgical Devices·760 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The ...
Surgical Devices·150 affected·Aug 10, 2016
High RiskFDA
Medline Industries Inc
Rigid Suction Canister 3000 CC and 2000 CC.
Medical Devices·7,680 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84" Tubing, Disposable Transducer, 3 mL Squeeze Flush, Ma...
Surgical Devices·4,180 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usage: The Transpac Disposable Straight Pressure Transducer...
Surgical Devices·20 affected·Aug 10, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Diagnostic Devices·0 affected·Aug 9, 2016
High RiskFDA
Zimmer Biomet, Inc.
Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:  Painful and disabled knee joint resulting from osteoarthritis, rheumato...
Medical Implants·5 affected·Aug 9, 2016
High RiskFDA
Global Healthcare Inc
MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientifi...
Medical Devices·282 affected·Aug 9, 2016
High RiskFDA
Mentor Texas, Lp.
CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correctio...
Medical Implants·30 affected·Aug 9, 2016
High RiskFDA
Mentor Texas, Lp.
MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used fo...
Medical Implants·70 affected·Aug 9, 2016
High RiskFDA
Zimmer Biomet, Inc.
Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product...
Medical Implants·31 affected·Aug 9, 2016
High RiskFDA
Mentor Texas, Lp.
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used fo...
Medical Implants·65 affected·Aug 9, 2016
High RiskFDA
Mentor Texas, Lp.
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correct...
Medical Implants·48 affected·Aug 9, 2016
High RiskFDA
Pharmatech Llc
CytoDetox, Hydrolyzed Clinoptilolite Fragments, 1 oz./30 mL, OTC Non-Sterile. Dietary supplement.
Supplements·1,990 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Poly-Vita Drops with Iron, 50 mL, OTC Non-Sterile. Dietary supplement.
Supplements·47,525 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
D3 Vitamin Liquid, 50 mL, OTC Non-Sterile. Dietary supplement.
Supplements·229,464 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Pedia Poly-Vite Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
Supplements·6,600 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Pedia Tri-Vite Drops with Iron, 50 mL, OTC Non-Sterile. Dietary supplement.
Supplements·6,024 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Polyvitamin Liquid, 50 mL, OTC Non-Sterile. Dietary supplement.
Supplements·188,640 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Fer-Iron Liquid, 50 mL, OTC Non-Sterile. Dietary supplement.
Supplements·99,024 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Ferrous Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
Supplements·31,224 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Poly-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
Supplements·42,984 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Renew HC, Hydrolyzed Clinoptilolite, 1 oz./30 mL, OTC Non-Sterile. Dietary supplement.
Supplements·62,228 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Virtrate-K, Potassium Citrate and Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement.
Supplements·8,232 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Polyvitamin Liquid with Iron, 50 mL, OTC Non-Sterile. Dietary supplement.
Supplements·201,784 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
D-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
Supplements·90,504 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Pedia Tri-Vite Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
Supplements·8,712 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Liquid Vitamin C, 4 oz./118 mL, OTC Non-Sterile. Dietary supplement.
Supplements·48,024 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Calcionate Syrup, Calcium Glubionate Syrup, 16 oz./473 mL, OTC Non-Sterile. Dietary supplement.
Supplements·6,048 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Virtrate-2, Sodium Citrate-Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement.
Supplements·34,612 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Tri-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
Supplements·23,736 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
CertaVite with Antioxidants, 8 oz./236 mL, OTC Non-Sterile. Dietary supplement.
Supplements·110,136 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Ferrous Sulfate Liquid, 16 oz./473 mL, OTC Non-Sterile. Dietary supplement.
Supplements·75,972 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Cerovite Liquid, 8 oz./236 mL, OTC Non-Sterile. Dietary supplement.
Supplements·129,268 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI ...
Drugs·19,656 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08.
Drugs·1,008 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 ...
Drugs·12,308 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Cen...
Drugs·5,928 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48...
Drugs·96,704 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, ...
Drugs·1,332 affected·Aug 8, 2016
High RiskFDA
Pharmatech Llc
Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 4...
Drugs·68,908 affected·Aug 8, 2016
High RiskFDA
Biomet 3i, Llc
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Medical Implants·92 affected·Aug 8, 2016
High RiskFDA
Nidek Inc
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, hi...
Medical Devices·29 affected·Aug 8, 2016
High RiskFDA
Becton Dickinson & Company
BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to...
Medical Devices·1,788,150 affected·Aug 8, 2016
High RiskFDA
Arrow International Inc
Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature ...
Surgical Devices·690 affected·Aug 8, 2016
High RiskFDA
Arrow International Inc
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small ve...
Surgical Devices·690 affected·Aug 8, 2016