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High RiskFDA
Datascope Corporation
BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
Medical Devices·4 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
Respiratory Devices·18 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 22701, Catalog No. 701050790
Medical Devices·4 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
Medical Devices·9 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
Medical Devices·40 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
Medical Devices·4 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
Medical Devices·3 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
Medical Devices·10 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
Medical Devices·18 affected·Oct 19, 2017
High RiskFDA
Johnson & Johnson Vision Care, Inc.
1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses
Medical Devices·56,070 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
Medical Devices·4 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
Medical Devices·6 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
Medical Devices·18 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
Medical Devices·9 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
Medical Devices·4 affected·Oct 19, 2017
High RiskFDA
Cook Inc.
Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Surgical Devices·1 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
Medical Devices·10 affected·Oct 19, 2017
High RiskFDA
Bioseal Corporation
Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309...
Surgical Devices·51,635 affected·Oct 18, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code...
Surgical Devices·5,926 affected·Oct 17, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
Surgical Devices·5,926 affected·Oct 17, 2017
High RiskFDA
Arrow International Inc
Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
Surgical Devices·5,926 affected·Oct 17, 2017
High RiskFDA
3m Company - Health Care Business
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Medical Devices·153 affected·Oct 17, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-C...
Surgical Devices·5,926 affected·Oct 17, 2017
High RiskFDA
Siemens Healthcare Diagnostics
BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -00842768...
Diagnostic Devices·7,631 affected·Oct 17, 2017
High RiskFDA
Arrow International Inc
Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
Surgical Devices·5,926 affected·Oct 17, 2017
High RiskFDA
Southmedic, Inc.
Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery devic...
Respiratory Devices·8,871 affected·Oct 17, 2017
High RiskFDA
Ion Beam Applications S.a.
Proteus 235, graphite block 8
Medical Devices·3 affected·Oct 17, 2017
High RiskFDA
Arrow International Inc
Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
Surgical Devices·5,926 affected·Oct 17, 2017
High RiskFDA
Arrow International Inc
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Featur...
Surgical Devices·5,926 affected·Oct 17, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 201...
Surgical Devices·5,926 affected·Oct 17, 2017
High RiskFDA
Arrow International Inc
ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
Medical Devices·601 affected·Oct 17, 2017
High RiskFDA
Arrow International Inc
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. D...
Surgical Devices·5,926 affected·Oct 17, 2017
High RiskFDA
Midway Specialty Vehicles Llc
Triple Chocolate Mudslide Cookie, 120 1 oz. cookies, frozen
Bakery & Grains·15,834 affected·Oct 16, 2017
High RiskFDA
Midway Specialty Vehicles Llc
Oatmeal Cookie, 60-2.5 oz. cookies, frozen
Bakery & Grains·11,764 affected·Oct 16, 2017
High RiskFDA
Midway Specialty Vehicles Llc
M&M Cookie, 60- 2.5 oz. cookies, frozen
Bakery & Grains·12,354 affected·Oct 16, 2017
High RiskFDA
Midway Specialty Vehicles Llc
Snickerdoodle Cookie, 60-2.5 oz. cookies, frozen
Bakery & Grains·23,820 affected·Oct 16, 2017
High RiskFDA
Midway Specialty Vehicles Llc
Chocolate Chip-N-Chunk Cookie, 72- 2 oz. cookies, frozen
Bakery & Grains·154,455 affected·Oct 16, 2017
High RiskFDA
Midway Specialty Vehicles Llc
Red Velvet Cookie, 60- 2.5 oz. cookies, frozen
Bakery & Grains·4,588 affected·Oct 16, 2017
High RiskFDA
Midway Specialty Vehicles Llc
Amish Sugar Cookie, 96- 1.5 oz. cookies, frozen
Bakery & Grains·3,737 affected·Oct 16, 2017
High RiskFDA
Midway Specialty Vehicles Llc
Iced Sugar Frosted Cookie, 60- 2.5 oz. cookies, frozen
Bakery & Grains·1,404 affected·Oct 16, 2017
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Inci...
Surgical Devices·5,946 affected·Oct 16, 2017
High RiskFDA
C.r. Bard, Inc.
Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a...
Medical Devices·24 affected·Oct 16, 2017
High RiskFDA
Normand Informatique
Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management System...
Medical Devices·34 affected·Oct 16, 2017
High RiskFDA
Fukuda Denshi Co., Ltd.
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Pati...
Cardiac Devices·6,227 affected·Oct 16, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a p...
Medical Devices·28 affected·Oct 16, 2017
High RiskFDA
Medtronic Minimally Invasive Therapies Group
MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Surgical Devices·0 affected·Oct 14, 2017
High RiskFDA
Wegmans Food Markets, Inc.
033710 - Wegmans Puff Fruit Dumplings, 2 Pack, 6 oz. UPC: 0 77890 33710 3
Produce·0 affected·Oct 13, 2017
High RiskFDA
Wegmans Food Markets, Inc.
549815- Fruit Fillings Inc. PERFECT NATURAL LEMON TART FILLING Net Weight 24 lb (10.88 kg) 12-2 lb tubes
Produce·65 affected·Oct 13, 2017