Z-1977-2018Class II
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features...
Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2018-04-11 / Terminated / root cause: packaging
Arrow International Inc began a recall of Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product... 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-1977-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- Product
- Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB
- Product code
- DYB Introducer, Catheter
- 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: 13F17D0180 13F17H0192 13F17K0223 13F17K0555
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.