Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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원인
Arrow international is recalling this product because the packaging may not be completely sealed. if the packaging is compromised in this manner the sterility of the product cannot be guaranteed. if a non-sterile product is used there is potential for infection to occur.
Model Catalog: ASK-15703-PRJ (Lot serial: 13F17D0112); Model Catalog: ASK-15703-PRJ (Lot serial: 13F17B0279); Model Catalog: ASK-12703-PRJ (Lot serial: 13F17B0279); Model Catalog: ASK-12703-PRJ (Lot serial: 13F17F0575); Model Catalog: ASK-15703-PRJ (Lot serial: 13F17F0575); Model Catalog: ASK-12703-PRJ (Lot serial: 13F17D0112); Model Catalog: CDA-21242-1A (Lot serial: 13F17F0437); Model Catalog: CDA 42802-P1A (Lot serial: 13F17D0039); Model Catalog: CA-42703-P1A (Lot serial: 13F17D0039); Model Catalog: CDA-42703-P1A (Lot serial: 13F17C0266); Model Catalog: CDA-45703-P1A (Lot serial: 13F17C0266); Model Catalog: CA-45703-P1A (Lot serial: 13F17C0266); Model Catalog: CDA 42802-P1A (Lot serial: 13F17C0266); Model Catalog: CA-42703-P1A (Lot serial: 13F17C0266); Model Catalog: CDA-42703-P1A (Lot serial: 13F17A0301); Model Catalog: CDA-45703-P1A (Lot serial: 13F17A0301); Model Catalog: CA-45703-P1A (Lot serial: 13F17A0301); Model Catalog: CDA 42802-P1A (Lot serial: 13F17A0301); Model Catalog: CA-42703-P1A (Lot seria
제품 설명
PERCUTANEOUS SHEATH INTRODUCER SET WITH ARROWG+ARD BLUE SHEATH;ARROWG+ARD BLUE MAC TWO-LUMEN CENTRAL VENOUS ACCESS KIT;AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT;ERCUTANEOUS SHEATH INTRODUCER KIT WITH ARROWG+ARD BLUE(R) SHEATH INTEGRAL HEMOSTASIS VALVE/