Z-1994-2018Class II
ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A...
Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2018-04-11 / Terminated / root cause: packaging
Arrow International Inc began a recall of 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 on . FDA classified it as Class II and gives the reason as "Product sterility may be compromised due to unsealed packaging". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1994-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- 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
- Product code
- FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Reason for recall
- Product sterility may be compromised due to unsealed packaging.
- Root cause tag
- packaging
- FDA root cause
- Under Investigation by firm
- Action
- On April 11, 2018 Arrow International mailed Urgent Medical Device Recall notifications to affected customers. Customers were instructed to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter. Customers with questions may contact your local sales representative or Customer Service at (866)246-6990.
- Quantity in commerce
- 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
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1957-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1958-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1959-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1960-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1961-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1962-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1963-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1964-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1965-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1966-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1967-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1968-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1969-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1970-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1971-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1972-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1973-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1974-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1975-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1976-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1977-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1978-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1979-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1980-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1981-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1982-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1983-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1984-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1985-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1986-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1987-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1988-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1989-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1990-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1991-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1992-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1993-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1994-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1995-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1996-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1997-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1998-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1999-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2000-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2001-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2002-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2003-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2004-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2005-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2006-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2007-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2008-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2009-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2010-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2011-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2012-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2013-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2014-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2015-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2016-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2017-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2018-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2019-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2020-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2021-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2022-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2023-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2024-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2025-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2026-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2027-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2028-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2029-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2030-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2031-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2032-2018 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.