Recall Z-1979-2018
Arrow International Inc · initiated April 11, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1
Codes / lots: Lot Numbers: 13F17B0389 13F17E0430 13F17F0580 13F17H0545 13F17K0403 13F17L0285
Reason for recall
Product sterility may be compromised due to unsealed packaging.
FDA-determined cause: Under Investigation by firm
Action taken
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 recalls@teleflex.com. 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 recalls@teleflex.com. 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.
Details
- Recall number
- Z-1979-2018
- Initiated
- April 11, 2018
- Terminated
- May 15, 2020
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- 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
- Recalling firm
- Arrow International Inc, Reading, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1957-2018 Class II | Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1958-2018 Class II | Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1959-2018 Class II | Echogenic Introducer Needle; Product Code: AN-04318Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1960-2018 Class II | Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1961-2018 Class II | Epidural Needle; Product Codes: AN-05501 and AN-05505Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1962-2018 Class II | SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1963-2018 Class II | Maximal Barrier Drape; Product Codes: ASK-00001-1AProduct sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1964-2018 Class II | Maximal Barrier Drape; Product Codes: ASK-00002-1AProduct sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1965-2018 Class II | Maximal Barrier Drape; Product Codes: ASK-00376-SUProduct sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1966-2018 Class II | Maximal Barrier Drape; Product Code: ASK-01000-UPMSProduct sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1967-2018 Class II | Maximal Barrier Drape; Product Code: ASK-04000-HMCProduct sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1968-2018 Class II | Radial Arterial Access Kit; Product Code: ASK-04001-BID2Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1969-2018 Class II | Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1970-2018 Class II | Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1971-2018 Class II | Arterial Catheterization Kit; Product Codes: ASK-04020-DHProduct sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1972-2018 Class II | Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes:…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1973-2018 Class II | Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HFProduct sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1974-2018 Class II | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1975-2018 Class II | Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1976-2018 Class II | Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1977-2018 Class II | Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1978-2018 Class II | Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1980-2018 Class II | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code:…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1981-2018 Class II | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code:…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1982-2018 Class II | ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr.…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1983-2018 Class II | MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1984-2018 Class II | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R)…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1985-2018 Class II | ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1986-2018 Class II | Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |
| Z-1987-2018 Class II | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue…Product sterility may be compromised due to unsealed packaging. | 04/11/2018Terminated |