ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen recall: Sterility Concern
ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
Why was ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen recalled?
Product sterility may be compromised due to unsealed packaging.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: Product Code CDC-45703-P1A: 13F17J0061 13F17J0084 13F17J0451 13F17K0249 13F17K0250 13F17K0383 13F17K0575 13F17L0576 13F17M0154 Product code CDC-45703-PB1A: 13F17B0350 13F17E0048 13F17E0719 13F17H0308 13F17L0099 Product code CDC-42703-P1A: 13F16M0232 13F17J0065 13F17J0450 13F17K0069 13F17K0136 13F17K0288 13F17K0419 13F17K0567 13F17L0223 13F17L0573 Product code CDC-15703-P1A: 13F17A0025 13F17E0279 13F17E0457 13F17F0160 13F17F0769 13F17G0349 13F17J0133 13F17J0134 13F17L0103 13F17M0200
- Product
- ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
- Recalling firm
- Arrow International Inc
- Quantity
- 416,055 total products
- Distribution
- US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
- Recall date
- June 6, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)