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High RiskFDA
Icu Medical, Inc.
7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps,...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI:...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per c...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10887709058757(17)250101(30)100(10)4573278; (01)108877090...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)2...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(10)4572842. Th...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pou...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches p...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Golden Technologies, Inc.
Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising f...
Medical Devices·251 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector, NanoClave¿ T-Connector, 4 Clamps (Red, White, Blue), Rotat...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)108877...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1 unit per pouch, 50 pouches per case. UDI:(01)10840619076...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per ...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)2502...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UDI:(01)10887709062...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)1...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit per pouch, 50 pouches per case. UDI:(01)108406190...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(0...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per ca...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. 1 unit per pouch, 50 pouches per case. UDI:(01)1088770907550...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Arrow International Inc
Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly t...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; ...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches p...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case. UDI...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit p...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clam...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(17)250201(30)50(1...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Teleflex Medical Inc
Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow dire...
Medical Devices·29,740 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619066052(17)25...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)24120...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Granules Pharmaceuticals Inc
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05),...
Oral Drugs·476,073 affected·Jul 3, 2020
High RiskFDA
Hostess Brands, Llc
Hostess Raspberry Zingers, Raspberry Iced Cake With Creamy Fillling, packaged in the following ways: 1) in boxes containing 10 cakes Net ...
Bakery & Grains·34,409 affected·Jul 2, 2020
High RiskFDA
Masterpharm Llc
Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15 mL), b) 2 FL OZ (60 mL) bottle, MasterPharm, 11...
Drugs·543 affected·Jul 2, 2020
High RiskFDA
Masterpharm Llc
Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Drugs·330 affected·Jul 2, 2020
High RiskFDA
Masterpharm Llc
Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Drugs·300 affected·Jul 2, 2020