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Crédits
Manufacturers
Olsen Medical
Adresse du fabricant
Olsen Medical, 3230 Commerce Center Pl, Louisville KY 40211-1900
Société-mère du fabricant (2017)
Olsen Medical Llc
Source
USFDA
5 Events
Rappel de Device Recall monopolar forceps
Rappel de Device Recall bipolar forceps
Rappel de Device Recall Monopolar Cord
Rappel de Device Recall bipolar cord
Rappel de Device Recall monopolar pencil
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5 dispositifs dans la base de données
Device Recall monopolar forceps
Modèle / numéro de série
all codes
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution
Description du dispositif
Symmetry Olsen monopolar forceps: || (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 || (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 || (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-2920K, QTY 10 || (d) Insulated Bayonet Forceps 7.5" (19.1cm) 1.5mm Cathedral Tips, REF 20-2960HK, QTY 10
Device Recall bipolar forceps
Modèle / numéro de série
all codes
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution
Description du dispositif
Symmetry Olsen bipolar forceps: || (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 || (b1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311R, QTY 5 || (c1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.0mm Tips, REF 20-0321, QTY 5 || (d1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.5mm Tips, REF 20-0331, QTY 5 || (e1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth, 1.5mm Tips, REF 20-0331R, QTY 5 || (f1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth Micro Tips, REF 20-0351, QTY 5 || (g1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 0.5mm Tips, REF 20-0361, QTY 5 || (h1) Insulated Irrigating Bayonet Forceps 7-1/8" (181.0mm) 0.5mm Tips, REF 20-0361G, QTY 5 || (i1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 0.5mm Tips, REF 20-0361R, QTY 5 || (j1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.0mm Tips, REF 20-0371, QTY 5 || (k1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.0mm Tips, REF 20-0371R, QTY 5 || (l1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.5mm Tips, REF 20-0381, QTY 5 || (m1)Insulated Irrigating Bayonet Forceps 7-1/8" (181.0mm) 1.5mm Tips, REF 20-0381G, QTY 5 || (n1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.5mm Tips, REF 20-0381R, QTY 5 || (o1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 0.5mm Tips, REF 20-0411, QTY 5 || (p1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 0.5mm Tips, REF 20-0411R, QTY 5 || (q1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.0mm Tips, REF 20-0421, QTY 5 || (r1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.0mm Tips, REF 20-0421R, QTY 5 || (s1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.5mm Tips, REF 20-0431, QTY 5 || (t1) Insulated Irrigating Bayonet Forceps 8.25" (309.6mm) 1.5mm Tips, REF 20-0431G, QTY 5 || (u1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.5mm Tips, REF 20-0431R, QTY 5 || (v1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.0mm Tips, REF 20-0481, QTY 5 || (w1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.0mm Tips, REF 20-0481R, QTY 5 || (x1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.5mm Tips, REF 20-0491, QTY 5 || (y1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.5mm Tips, REF 20-0491R || (z1) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 0.5mm Tips, REF 20-0571IMT, QTY 5 || (a2) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 1.0mm Tips, REF 20-0572IMT, QTY 5 || (b2) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 1.5mm Tips, REF 20-0573IMT, QTY 5 || (c2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 0.5mm Tips, REF 20-0581IMT, QTY 5 || (d2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 1.0mm Tips, REF 20-0582IMT, QTY 5 || (e2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 1.5mm Tips, REF 20-0583IMT, QTY 5 || (f2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 0.5mm Tips, REF 20-0591IMT, QTY 5 || (g2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 1.0mm Tips, REF 20-0592IMT, QTY 5 || (h2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 1.5mm Tips, REF 20-0593IMT || (i2) Insulated Coaptation Forceps 4.5" (11.4cm) Smooth Micro Tips, Angled, REF 20-1010KI, QTY 10 || (j2) Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, REF 20-1030K, QTY 10 || (k2) Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, Angled 45o, REF 20-1040K, QTY 10 || (l2) Insulated Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, Angled 45o, REF 20-1040KI, QTY 10 || (m2) Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060K, QTY 10 || (n2) Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060K-28, QTY 10 || (o2) Insulated Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060KI, QTY 10 || (p2) Insulated Jewelers Forceps 4.5" (11.4cm) Smooth Micro Ti
Device Recall Monopolar Cord
Modèle / numéro de série
all codes
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution
Description du dispositif
Symmetry Olsen monopolar cord: || (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 || (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 || (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 || Designed to bring high frequency electrical power from the electrosurgical generator to the active.
Device Recall bipolar cord
Modèle / numéro de série
all codes
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution
Description du dispositif
Symmetry Olsen bipolar cord: || (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 || (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 || (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 || (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1103, QTY 50 || (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.6m), REF 40-1104, QTY 10 || (f) Bipolar Cord, 28 mm Fixed Pin Connector, REF 40-1105-28, QTY 10 || (g) Bipolar Cord, 39 mm Fixed Pin Connector, REF 40-1105-39, QTY 10 || (h) Bipolar Cord, 28 mm Fixed Pin Connector, Angled 45o, REF 40-1106-28, QTY 10 || (i) Bipolar Cord, Twin Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1113, QTY 10 || (j) Bipolar Cord, Wolf to Wolf Kleppinger, 12' (3.6m), REF 40-1114, QTY 10 || (k) Bipolar Cord, 28 mm Fixed Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1115-28, QTY 10 || (l) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3001R, QTY 10 || (m) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3003-R-39, QTY 10 || (n) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF G-40-1102, QTY 10 || Intended for use in coagulating tissue.
Device Recall monopolar pencil
Modèle / numéro de série
all codes
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution
Description du dispositif
Symmetry Olsen Monopolar Pencil: || (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 || (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 || (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 || (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF 75800, QTY 25 || (e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure, REF 75810, QTY 25 || (f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure, REF 75820, QTY 25 || (g) Foot Controlled Handle, w / Standard Blade electrode, REF 95012, QTY 100 || Designed to hold active electrodes.
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Olsen Medical
Adresse du fabricant
Olsen Medical, 3001 W Kentucky St, Louisville KY 40211-1505
Source
USFDA
OLSEN MEDICAL LLC
Adresse du fabricant
LOUISVILLE
Société-mère du fabricant (2017)
Olsen Medical Llc
Source
HC
Language
English
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