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Devices
Device Recall Disetronic
모델명 / 제조번호(시리얼번호)
Lot 3G039UF.
의료기기 분류등급
General Hospital and Personal Use Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
제품 설명
Disetronic Ultraflex 8/80 infusion set; Catalog number 4489039001. (Distributed outside of the US only).
Manufacturer
Disetronic Medical Systems, Inc.
1 Event
Device Recall Disetronic 의 리콜
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제조사
Disetronic Medical Systems, Inc.
제조사 주소
Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
Source
USFDA
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Device Recall Disetronic DTron
모델명 / 제조번호(시리얼번호)
All units with the following lot numbers being used by patients 13 years of age or younger: lots 4013674 through 4022628. The last affected lot expires in April 2007.
의료기기 분류등급
General Hospital and Personal Use Devices
의료기기 등급
2
이식된 장치?
No
유통
Nationwide.
제품 설명
Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.
Manufacturer
Roche Diagnostics Corp.
Device Recall Disetronic
모델명 / 제조번호(시리얼번호)
Lot 3H003UF.
의료기기 분류등급
General Hospital and Personal Use Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
제품 설명
Disetronic Ultraflex 8/60 infusion set; (Distributed outside of the US only).
Manufacturer
Disetronic Medical Systems, Inc.
Device Recall Disetronic
모델명 / 제조번호(시리얼번호)
Lot 3J012UF.
의료기기 분류등급
General Hospital and Personal Use Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
제품 설명
Disetronic Ultraflex 8/110 infusion set; (Distributed outside of the US only).
Manufacturer
Disetronic Medical Systems, Inc.
Device Recall Disetronic
모델명 / 제조번호(시리얼번호)
Lot 3H067UF.
의료기기 분류등급
General Hospital and Personal Use Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
제품 설명
Disetronic Ultraflex 10/110 infusion set; (Distributed outside of the US only).
Manufacturer
Disetronic Medical Systems, Inc.
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