Z-1994-2018 Class II Terminated
FDA device recall Z-1994-2018 was initiated by Arrow International Inc on Apr 11, 2018 and is designated Class II. Reason for recall: Product sterility may be compromised due to unsealed packaging. The recall status is terminated (terminated May 15, 2020). Affected quantity: 416,055 total products.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 6, 2018
- Initiation Date
- Apr 11, 2018
- Termination Date
- May 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 416,055 total products
Product Description
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
Reason for Recall
Product sterility may be compromised due to unsealed packaging.
Distribution Pattern
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
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1994-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026