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 the referenced products because some of the products may be missing a sticker that contains the lot number expiration date and unique device identification (udi) information.
Model Catalog: ASK15703-PRJ (Lot serial: 13F17D0112); Model Catalog: ASK-12703-PRJ (Lot serial: 13F17D0112); Model Catalog: ASK15703-PRJ (Lot serial: 13F17B0279); Model Catalog: ASK-12703-PRJ (Lot serial: 13F17B0279); Model Catalog: ASK15703-PRJ (Lot serial: 13F17B0265); Model Catalog: ASK-12703-PRJ (Lot serial: 13F17B0265); Model Catalog: CDA-21242-1A (Lot serial: 13F17H0503); Model Catalog: CDA-21242-1A (Lot serial: 13F16L0209); Model Catalog: CDA-21242-1A (Lot serial: 13F17F0437); Model Catalog: CDA-47702-P1A (Lot serial: 13F17H0566); Model Catalog: CDA-45703-P1A (Lot serial: 13F17H0566); Model Catalog: CDA-42802-P1A (Lot serial: 13F17H0566); Model Catalog: CDA-42703-P1A (Lot serial: 13F17H0566); Model Catalog: CA-45703-P1A (Lot serial: 13F17H0566); Model Catalog: CA-42703-P1A (Lot serial: 13F17H0566); Model Catalog: CDA-47702-P1A (Lot serial: 13F17G0541); Model Catalog: CDA-45703-P1A (Lot serial: 13F17G0541); Model Catalog: CDA-42802-P1A (Lot serial: 13F17G0541); Model Catalog: CDA-42703-P1A (Lot serial:
제품 설명
CENTRAL VENOUS CATHETERIZATION KITS/SETS;TWO-LUMEN CENTRAL VENOUS ACCESS KIT;AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT;PERCUTANEOUS SHEATH INTRODUCER SET;ARROWG+ARD BLUE PLUS CENTRAL VENOUS CATHETER KITS;ARROWG+ARD BLUE PLUS CENTRAL VENOUS CATHETER KIT