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Crédits
Devices
Device Recall Irrigation Kit
Modèle / numéro de série
Catalog number: 6115, Lot numbers: 11266, 11418, 12116, 12275, 12769, 13158, 13317, 13550, 13738, 14948, 15783, 15991, 16884, 17383, 17958, 18911, 19761.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.
Description du dispositif
Irrigation Kit, Medium, Vinyl, REF: 6115, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. || Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
Manufacturer
Apogee Medical
1 Event
Rappel de Device Recall Irrigation Kit
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Fabricant
Apogee Medical
Adresse du fabricant
Apogee Medical, 90 Hearther Ct, Youngsville NC 27596
Source
USFDA
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Device Recall Irrigation Kit
Modèle / numéro de série
Catalog number: 6111, Lot numbers: 11027, 11119, 11262, 11414, 11695, 11882, 12114, 12271, 12586, 12888, 13080, 13316, 13527, 13548, 13736, 13979, 14091, 14093, 14457, 14732, 14945, 14946, 15781, 15989, 16414, 16424, 16633, 16882, 17016, 17381, 17574, 17576, 17956, 18127, 18475, 19450, 19557.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.
Description du dispositif
Irrigation Kit, Large, Latex, REF: 6111, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. || Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
Manufacturer
Apogee Medical
Device Recall Irrigation Kit
Modèle / numéro de série
Catalog number: 6112, Lot numbers: 11120, 11263, 11415, 11696, 11881, 12115, 12272, 12635, 12955, 13199, 13547, 13737, 14092, 14944, 14949, 15988, 16183, 16425, 16883, 17380, 17575, 17957, 18477, 18909, 19556, 19760.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.
Description du dispositif
Irrigation Kit, Medium, Latex, REF: 6112, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. || Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
Manufacturer
Apogee Medical
Device Recall Irrigation Kit
Modèle / numéro de série
Catalog number: 6113, Lot numbers: 11264, 11416, 12273, 13273, 14094.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.
Description du dispositif
Irrigation Kit, Small, Latex, REF: 6113, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. || Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
Manufacturer
Apogee Medical
Device Recall Irrigation Kit
Modèle / numéro de série
Catalog number: 6114, Lot numbers: 11121, 11265, 11417, 11697, 11883, 12274, 12621, 12768, 13006, 13315, 13318, 13549, 13739, 14095, 14947, 15782, 15990, 17017, 17382, 17730, 18476, 18910, 19555, 19759, 20021.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.
Description du dispositif
Irrigation Kit, Large, Vinyl, REF: 6114, Apogee Medical, LLC, 90 Weathers Street, Bournesville, NC 27596. || Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
Manufacturer
Apogee Medical
Device Recall Irrigation Kit
Modèle / numéro de série
Catalog number: 6115, Lot numbers: 11267, 11419, 12622.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.
Description du dispositif
Irrigation Kit, Small, Vinyl, REF: 6116, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. || Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
Manufacturer
Apogee Medical
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