Devices

Device Recall SODASORB 48 IND H MED

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers CN12-P115-02, CN12-P115-03, CN12-P115-04, CN12-P115-05, CN12-P115-07, CN12-P115-08, CN12-P115-09, CN12-P115-10, CN12-P115-11, CN12-P115-12, CN12-P115-13, CN12-P115-14, CP01-P115-01, CP01-P115-02, CP01-P115-03, CP01-P115-04, CP01-P115-05, CP01-P115-08, CP01-P115-10, CP01-P115-11, CP01-P115-12, CP01-P115-15, CP01-P115-16, CP01-P115-17, CP01-P115-18, CP01-P115-19, CP01-P115-20, CP01-P115-21, CP01-P115-22 and CP01-P115-23.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, Canada, the Philippines, Australia, Brazil, Chile, Dominican Republic, Korea and Japan.
  • 제품 설명
    Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; Manufactured by: W.R. Grace & Company, 6050 West 51st Street, Chicago, IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters, 12 per carton), canister paks (pre-measured 2.5 lb. bags, 12 per carton), 5-gallon pails and 55-gallon drums under the W.R. Grace label and the Portex label distributed by Sims Portex Inc., Keene, NH 03431
  • Manufacturer
    Darex Container Products Div of W.R. Grace & Co.
  • 1 Event

제조사

Darex Container Products Div of W.R. Grace & Co.
  • 제조사 주소
    Darex Container Products Div of W.R. Grace & Co., 6050 W. 51st Street, Chicago IL 60639
  • Source
    USFDA

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Device Recall SODASORB 48 IND H MED
  • 모델명 / 제조번호(시리얼번호)
    pre-paks lot CR10-P115-14, exp. 10/2006, and 5-gallon pail lot CR09-P115-30, exp. 9/2006
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    California, Connecticut, Pennsylvania, Maine, Massachusetts, MIssissippi, New Hampshire, New Jersey, New York, Vermont, Virginia and West Virginia
  • 제품 설명
    Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; Manufactured by: W.R. Grace & Co. - Conn., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters, 12 per carton) and 5-gallon pails
  • Manufacturer
    Darex Container Products Div of W.R. Grace & Co.