Devices

Device Recall RUSCH ENDOBRONCHIAL TUBE SETS

모델명 / 제조번호(시리얼번호)
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
의료기기 분류등급
Anesthesiology Devices
의료기기 등급
2
이식된 장치?
No
유통
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
제품 설명
Bronchial One Lumen Tube - Right
Manufacturer
Teleflex, Inc.
1 Event
- Device Recall RUSCH ENDOBRONCHIAL TUBE SETS 의 리콜

제조사

Teleflex, Inc.

제조사 주소
Teleflex, Inc., 550 E Swedesford Rd Ste 400, Wayne PA 19087-1601
제조사 모회사 (2017)
Teleflex Incorporated
Source
USFDA

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Device Recall RUSCH ENDOBRONCHIAL TUBE SETS

모델명 / 제조번호(시리얼번호)
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
의료기기 분류등급
Anesthesiology Devices
의료기기 등급
2
이식된 장치?
No
유통
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
제품 설명
Bronchial Double Lumen Tube Set (Left), Sterile
Manufacturer
Teleflex, Inc.

Device Recall RUSCH ENDOBRONCHIAL TUBE SETS

모델명 / 제조번호(시리얼번호)
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
의료기기 분류등급
Anesthesiology Devices
의료기기 등급
2
이식된 장치?
No
유통
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
제품 설명
Tracheopart Set (Left), Sterile
Manufacturer
Teleflex, Inc.

Device Recall RUSCH ENDOBRONCHIAL TUBE SETS

모델명 / 제조번호(시리얼번호)
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
의료기기 분류등급
Anesthesiology Devices
의료기기 등급
2
이식된 장치?
No
유통
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
제품 설명
Bronchial Double Lumen Tube Set (Right), Sterile
Manufacturer
Teleflex, Inc.

Device Recall RUSCH ENDOBRONCHIAL TUBE SETS

모델명 / 제조번호(시리얼번호)
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
의료기기 분류등급
Anesthesiology Devices
의료기기 등급
2
이식된 장치?
No
유통
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
제품 설명
Bronchial One Lumen Tube - Left
Manufacturer
Teleflex, Inc.

Device Recall RUSCH ENDOBRONCHIAL TUBE SETS

모델명 / 제조번호(시리얼번호)
Product Code 116101370 Batch Number 13KT12, 13LT04; Product Code 116101390 Batch Number 13KT18; Product Code 116101410 Batch Number 13FT12R, 13GT05, 13JT11, 13JT15; Product Code 116101-000350 Batch Numbers 14JT14; Product Code 116101-000370 Batch Numbers 13FT06, 13FT12, 13FT18, 13GT05, 13GT29, 13HT07, 13HT12, 13HT17, 13IT16, 13IT20R, 13JT08, 13JT21, 13KT12, 13KT18, 13LT04, 13LT14, 14AT08, 14BT14, 14BT15, 14CT11, 14CT16, 14DT10, 14DT15, 14DT19, 14DT24, 14ET10, 14ET11, 14ET22, 14FT04, 14FT05, 14FT10, 14FT13, 14GT10, 14GT11, 14GT15, 14GT21, 14HT17, 14IT05, 14IT11, 14JT09, 14JT14; Product Code 116101-000390 Batch Numbers 13FT06, 13FT12, 13GT05, 13GT23, 13GT29, 13HE35, 13HT17, 13IT05, 13IT16, 13IT20, 13IT20R, 13JT08, 13JT21, 13KT12, 13KT15, 13KT18, 13LT04, 13LT11, 14BT14, 14BT21, 14CT11, 14CT21, 14DT03, 14DT13, 14DT15, 14DT19, 14DT20, 14DT25, 14ET04, 14ET28, 14FT04, 14FT16, 14GT10, 14GT11, 14GT21, 14GT23R, 14HT17, 14HT23, 14HT24, 14IT08, 14JT09, 14JT12; Product Code 116101-000410 - Batch Number 13FT06, 13FT12, 13GT05, 13GT24, 13GT29, 13HT07, 13HT12, 13HT17, 13IT16, 13IT20R, 13JT08, 13JT11, 13JT15, 13JT21, 13KT12, 13KT15, 13KT23, 13LT08, 13LT14, 13LT18, 14AT20, 14BT21, 14CT11, 14CT16, 14CT20, 14DT13, 14DT19, 14ET05, 14ET10, 14ET28, 14FT13, 14FT16, 14GT15, 14GT18, 14GT21R, 14HT03, 14HT17, 14HT23, 14HT24, 14JT09
의료기기 분류등급
Anesthesiology Devices
의료기기 등급
2
이식된 장치?
No
유통
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
제품 설명
Carlens Bronchial Double Lumen Tube Set (Left) Sterile
Manufacturer
Teleflex, Inc.

하나 더 3 건 더

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