Devices

Device Recall RUSCH

  • Model / Serial
    Catalogue number: 76816, Lot number 0J005.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: AZ, CA, FL, GA, IL, KS, KY, LA, MA, MS, NC, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WI including Puerto Rico.
  • Product Description
    ***** EXPANDED RECALL ***** || Rusch Foley Catheter Insertion Tray with Preconnected Bag and 16 Fr. Catheter, Manufactured for and distributed by Teleflex Medical, Research Triangle Park, NC 57708 || Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.
  • Manufacturer
    Teleflex Medical
  • 1 Event

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA

37 devices with a similar name

Learn more about the data here

Device Recall RUSCH ENDOBRONCHIAL TUBE SETS
  • Model / Serial
    Product Code 116100260  Batch Number 13GT24, 13HT07, 13IT16, 13KT23, 14AT08, 14DT19, 14ET10, 14ET11, 14FT04, 14FT10, 14GT03; Product Code 116100280  Batch Number 13GT24, 13KT05, 13KT23, 14AT12, 14ET23; Product Code 116100350  Batch Number 13GT24, 13HT07, 13IT16, 13JT08, 13KT05, 13KT18, 13KT23, 13LT14, 14CT06, 14DT10, 14DT19, 14ET23; Product Code 116100370  Batch Number 13GT11, 13GT24, 13HT07, 13IT16, 13JT25, 13KT23, 13LT04, 13LT18, 14CT11, 14DT13, 14DT19, 14DT24, 14DT25, 14ET10, 13ET11; Product Code 116100390  Batch Number 13FT12R, 13HT07, 13IT16, 13JT11, 13JT15, 13JT25, 13KT18, 13KT23, 14AT12R, 14BT09, 14ET10, 14ET11; Product Code 116100410  Batch Number 13FT12R, 13GT05, 13HT07, 13IT20, 13JT25, 13KT05, 13KT18, 13LT18, 14DT19, 14ET04, 14ET10, 14ET11, 14FT05, 14FT10; Product Code 116100-000260  Batch Number 13FT12, 13FT17, 13GT24, 13HT07, 13HT12, 13HT17, 13IT05, 13IT10, 13IT20, 13IT20R, 13JT05R, 13LT04, 14BT15, 14BT16, 14CT16, 14DE14J, 1DT13, 14ET04, 14ET10, 14GT03, 14GT15, 14GT21, 14HT09, 14HT12, 14HT20, 14IT05, 14IT08, 14JT12, 14JT24; Product Code 116100-000280  Batch Number 13GT16, 13GT23, 13HT17, 13IT10, 13IT13, 13IT16, 13IT20, 13IT20R, 13JT08, 13KT05, 13KT18, 13KT23, 14AT08, 14AT12, 14BT16, 14CT06, 14CT11, 14CT16, 14DE14J, 14DT10, 14DT19, 14DT20, 14DT24, 14ET04, 14ET10, 14ET22, 14ET23, 14FT04, 14FT05, 14GT03, 14GT18, 14HT20, 14IT14, 14JT12; Product Code 116100-000350  Batch Number 13FT06, 13FT12, 13FT17, 13FT18, 13GT23, 13GT24, 13HT07, 13HT12, 13HT17, 13IE36R, 13IT05, 13IT10, 13IT16, 13JT08, 13JT11, 13JT25, 13KT05, 13KT12, 13KT18, 13KT23, 13LT04, 13LT14, 14AT08, 14AT16, 14BT15, 14BT21, 14CT11, 14CT16, 14CT20, 14DT10, 14DT13, 14DT15, 14DT19, 14ET04, 14ET05, 14ET22, 14ET23, 14ET28, 14FT04, 14GT05, 14GT10, 14HT09, 14HT12, 14HT17, 14HT20, 14IT05, 14IT17, 14JT04, 14JT09, 14JT12, 14JT21, 14JT24; Product Code 116100-000370  Batch Number 13FT06, 13FT12, 13FT18, 13GE27J, 13GE31J, 13GT05, 13GT11, 13GT16, 13GT24, 13GT29, 13HT07, 13HT12, 13HT17, 13IT05, 13IT10, 13IT16, 13IT20R, 13JT05, 13JT05R, 13JT08, 13JT15, 13JT21, 13KT05, 13KT12, 13KT15, 13LT04, 13LT11, 13LT14, 13LT18, 14AT08, 14AT12, 14AT16, 14AT20, 14BT14, 14BT15, 14BT16, 14CT06, 14CT11, 14CT21, 14DT03, 14DT10, 14DT13, 14DT24, 14DT25, 14ET04, 14ET10, 14ET22, 14ET23, 14ET28, 14FE23J, 14FT04, 14FT05, 14FT10, 14GT03, 14GT05, 14GT10, 14GT15, 14GT18, 14GT23R, 14HT09, 14HT12, 14HT17, 14HT23, 14HT24, 14IT05, 14IT08, 14IT11, 14IT17, 14JT04, 14JT12, 14JT18, 14JT21, 14JT24; Product Code 116100-000390  Batch Number 13FT06, 13FT12, 13FT17, 13FT18, 13GT05, 13GT16, 13GT24, 13GT29, 13HE35, 13HT07, 13HT16, 13HT17, 13IT10, 13IT13, 13JT05, 13JT08, 13JT11, 13JT15, 13JT20, 13JT21, 13JT25, 13KT05, 13KT12, 13KT18, 13KT23, 13LT04, 13LT14, 14BT09, 14BT14, 14BT15, 14BT16, 14BT21, 14CT06, 14CT11, 14CT20, 14DT03, 14DT06, 14DT10, 14DT13, 14DT15, 14DT24, 14DT25, 14EE21J, 14ET04, 14ET10, 14ET22, 14ET28, 14FT04, 14FT05, 14FT10, 14FT13, 14GT03, 14GT05, 14GT15, 14GT18, 14HT03R, 14HT09, 14HT12, 14HT17, 14IT05, 14IT11, 14IT14, 14IT17, 14JT04, 14JT09, 14JT12, 14JT21; Product Code 116100-000410 - Batch Number 13FT06, 13FT12, 13FT18, 13GT05, 13GT11, 13GT16, 13GT23, 13GT29, 13HT07, 13HT12, 13HT17, 13IT05, 13IT10, 13IT16, 13IT20, 13IT20R, 13JT08, 13JT15, 13KT05, 13KT12, 13KT18, 13KT23, 13LT04, 13LT08, 13LT14, 13LT18, 14AT08, 14AT16, 14AT20, 14BT15, 14CT06,14CT11, 14CT16, 14CT20, 14DT06, 14DT10, 14DT13, 14DT24,14EE21J, 14ET04, 14ET05, 14ET10, 14ET22, 14FT10, 14FT13, 14FT16, 14FT20, 14GT05, 14GT15, 14GT18, 14HT03, 14HT09, 14HT17, 14HT24, 14IT05, 14IT08, 14IT17, 14JT09, 14JT12, 14JT21; Product Code 16100-000350  Batch Number 14DE14J, 14FE24J, 14GE28J
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago
  • Product Description
    Bronchial Double Lumen Tube Set (Left), Sterile
  • Manufacturer
    Teleflex, Inc.
Device Recall RUSCH ENDOBRONCHIAL TUBE SETS
  • Model / Serial
    Produce Code 116400-000750  Batch Number 13FT06, 13GE28J, 13GE31J, 13GT11, 13GT29, 13IT05, 13IT16, 13JT11, 13JT21R, 13JT25R, 13KT05R, 13LT11, 14BT09, 14BT15, 14CT16, 14CT20, 14DE16J, 14DT19, 14FE24J, 14FT16, 14GE29J, 14GT03, 14GT23, 14HT03, 14HT23, 14IT05, 14IT17; Product Code 116400-000850  Batch Number 13FT18, 13GE31J, 13GT05, 13HT17, 13IT13, 13JT15, 13JT20, 13JT20R, 13KT23R, 13LT08, 14BT09, 14BT15, 14CT16, 14CT20, 14DE15J, 14DT08, 14FE24J, 14FT13, 14GE28J, 14GT18, 14GT21, 14HT09, 14IT05, 14IT14, 14JT04, 14JT12; Product Code 116400-000950  Batch Number 13GE30J, 13GT29, 13HT16, 13IT13, 13LT08, 14AE05J, 14DT10, 14ET11, 14FT04, 14GT21, 14IT08, 14IT14, 14JE43J, 14JT18, 14JT24
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago
  • Product Description
    Tracheopart Set (Left), Sterile
  • Manufacturer
    Teleflex, Inc.
Device Recall RUSCH ENDOBRONCHIAL TUBE SETS
  • Model / Serial
    Product Code 162000260 Batch Number 14CT11; Product Code 116200280 Batch Number 13JT05, 13KT18, 14CT11, 14FT05, 14FT10; Product Code 116200350 Batch Number 13FT12R, 13GT11, 13HT07, 13KT23, 14AT08; Product Code 116200370 Batch Number 13KT23, 13LT14, 14DT25, 14ET23; Product Code 116200390 Batch Number 13HT12, 13JT08, 13KT18, 14ET10; Product Code 116200410 Batch Number 14ET05, 14ET22; Product Code 116201350 Batch Number 13FT12R, 13GT05; Product Code 116201410 Batch Number 14ET04; Product Code 116200-000260 Batch Number 13FT12, 13GE29J, 13GT29, 13HT12, 13HT17, 13IT10, 13JT05R, 13JT21, 13LT04, 14DT03, 14ET04, 14ET10, 14ET22, 14FT04, 14GT11, 14GT18, 14GT21, 14HT09, 14HT17; Product Code 116200-000260 - Batch Number 13FT12, 13GE29J, 13GT29, 13HT12, 13HT17, 13IT10, 13JT05R, 13JT21, 13LT04, 14DT03, 14ET04, 14ET10, 14ET22, 14FT04, 14GT11, 14GT18, 14GT21, 14HT09, 14HT17; Product Code 116200-000280 Batch Number 13FT06, 13FT12, 13GE29J, 13HT12, 13HT17, 13IT10, 13JT11, 13KT05, 13KT18, 13LT11, 14CT06, 14CT21, 14DT10, 14DT24, 14ET10, 14ET22, 14FT04, 14FT10, 14GT03, 14GT15, 14GT21, 14HT09, 14IT05, 14IT20; Product Code 116200-000350 Batch Number 13GE28J, 13GT05, 13GT11, 13GT23, 13GT29, 13HT07, 13HT12, 13HT17, 13IT10, 13IT13, 13JT08, 13JT20, 13JT21, 13KT05, 13KT12, 13KT23, 13LT04, 13LT08, 13LT11, 14AT04, 14AT08, 14BT21, 14CT06, 14CT16, 14CT20, 14CT21, 14DT06, 14DT24, 14ET04, 14ET05, 14FT22, 14FT04, 14FT10, 14FT13, 14FT20, 14GT05, 14GT15, 14HT09, 14HT20, 14HT23, 14IT05, 14IT08, 14JT09, 14JT12, 14JT24; Product Code 116200-000370 Batch Number 13FT17, 13GE28J, 13GT05, 13GT16, 13HT12, 13IT05, 13IT10, 13IT16, 13IT20R, 13JT08, 13JT15, 13KT05, 13KT12, 13KT23, 13LT08, 13LT14, 14AT08, 14AT12, 14BT21, 14CT06, 14CT16, 14DT03, 14DT13, 14DT19, 14DT20, 14DT24, 14DT25, 14ET05, 14ET23, 14ET28, 14FT04, 14FT13, 14FT20, 14GT03, 14GT18, 14HT03, 14HT09, 14HT12, 14HT17, 14IT08, 14IT17, 14JT21, 14JT24; Product Code 116200-000390 Batch Number 13FT12, 13FT18, 13GE28J, 13GT16, 13GT29, 13HT12, 13IT05, 13IT10, 13IT13, 13IT20, 13IT20R, 13JT05R, 13JT08, 13JT15, 13JT20R, 13KT05, 13KT18, 13LT08, 14BT15, 14BT16, 14BT21, 14CT11, 14CT16, 14DT13, 14DT15, 14ET04, 14ET10, 14FT04, 14FT16, 14GT03, 14GT15, 14GT21, 14HT03, 14HT17, 14HT23, 14IT05, 14IT08, 14IT17, 14IT20, 14JT12, 14JT24; Product Code 116200-000410 Batch Number 13FT12, 13GE30J, 13GT11, 13GT24, 13GT29, 13HT12, 13HT17, 13IT10, 13IT13, 13IT20R, 13JT05, 13JT05R, 13JT20, 13KT05, 13KT12, 13LT04, 13LT08, 14AT08, 14BT21, 14CT11, 14DT13, 14DT15, 14DT19, 14DT24, 14ET04, 14ET05, 14ET22, 14FT13, 14GT15, 14GT21, 14HT03, 14HT09, 14HT17, 14HT20, 14HT23, 14IT08
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago
  • Product Description
    Bronchial Double Lumen Tube Set (Right), Sterile
  • Manufacturer
    Teleflex, Inc.
Device Recall RUSCH ENDOBRONCHIAL TUBE SETS
  • Model / Serial
    Product Code 115900-000065 Batch Number 13FT06, 13GT24, 13JT08, 13KT12, 13LT08, 14AT20, 14DT19, 14ET04, 14GT10, 14GT15, 14IT11, 14JT09, 14JT24; Product Code 115900-000080 Batch Number 13FT17, 13IT11, 13KT05, 13KT12, 14AT04, 14BT04, 14BT15, 14DT19, 14ET04, 14ET22, 14GT15, 14GT18, 14IT14, 14JT09, 14JT18
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago
  • Product Description
    Bronchial One Lumen Tube - Left
  • Manufacturer
    Teleflex, Inc.
Device Recall RUSCH ENDOBRONCHIAL TUBE SETS
  • Model / Serial
    Product Code 115901-000065 Batch Number 13FT06, 13IT05, 13JT08, 13KT12, 14CT11, 14DT03, 14DT24, 14ET04, 14FT04, 14FT20, 14GT10; Product Code 115901-000080 - Batch Number 13GT16, 13KT18, 13LT08, 14CT11, 14DT03, 14DT24, 14GT15, 14HT12, 14HT20, 14JT04, 14JT12, 14JT21
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago
  • Product Description
    Bronchial One Lumen Tube - Right
  • Manufacturer
    Teleflex, Inc.
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