Recall Z-1958-2018

Arrow International Inc · initiated April 11, 2018

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N

Codes / lots: Lot Numbers: 13F17G0253 13F17A0200 13F17F0505 13F17G0256 13F17J0455 13F17C0193 13F17K0105 13F17C0198 13F17J0280 13F17A0063 13F17A0061 13F17B0252 13F17F0190 13F17L0701 13F17A0064 13F17C0225 13F17D0342 13F17J0229 13F17K0592 13F17M0002 13F17A0201 13F17D0246

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-1958-2018
Initiated
April 11, 2018
Terminated
May 15, 2020
Product code
CAZ – Anesthesia Conduction Kit
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

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1957-2018 Class IICatheter 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-1959-2018 Class IIEchogenic Introducer Needle; Product Code: AN-04318Product sterility may be compromised due to unsealed packaging. 04/11/2018Terminated
Z-1960-2018 Class IISpring 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 IIEpidural Needle; Product Codes: AN-05501 and AN-05505Product sterility may be compromised due to unsealed packaging. 04/11/2018Terminated
Z-1962-2018 Class IISnapLock" Catheter/Syringe Adapter; Product Code: AS-05500Product sterility may be compromised due to unsealed packaging. 04/11/2018Terminated
Z-1963-2018 Class IIMaximal Barrier Drape; Product Codes: ASK-00001-1AProduct sterility may be compromised due to unsealed packaging. 04/11/2018Terminated
Z-1964-2018 Class IIMaximal Barrier Drape; Product Codes: ASK-00002-1AProduct sterility may be compromised due to unsealed packaging. 04/11/2018Terminated
Z-1965-2018 Class IIMaximal Barrier Drape; Product Codes: ASK-00376-SUProduct sterility may be compromised due to unsealed packaging. 04/11/2018Terminated
Z-1966-2018 Class IIMaximal Barrier Drape; Product Code: ASK-01000-UPMSProduct sterility may be compromised due to unsealed packaging. 04/11/2018Terminated
Z-1967-2018 Class IIMaximal Barrier Drape; Product Code: ASK-04000-HMCProduct sterility may be compromised due to unsealed packaging. 04/11/2018Terminated
Z-1968-2018 Class IIRadial Arterial Access Kit; Product Code: ASK-04001-BID2Product sterility may be compromised due to unsealed packaging. 04/11/2018Terminated
Z-1969-2018 Class IIArterial 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 IIRadial 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 IIArterial Catheterization Kit; Product Codes: ASK-04020-DHProduct sterility may be compromised due to unsealed packaging. 04/11/2018Terminated
Z-1972-2018 Class IIRadial 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 IIRadial 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 IISingle-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 IIArrow-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 IIPercutaneous 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 IIPercutaneous 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 IITwo-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-1979-2018 Class IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)…Product sterility may be compromised due to unsealed packaging. 04/11/2018Terminated
Z-1980-2018 Class IIPressure 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 IIPressure 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 IIARROWg+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 IIMAC(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 IISingle-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 IIARROWg+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 IIPercutaneous 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 IIMulti-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue…Product sterility may be compromised due to unsealed packaging. 04/11/2018Terminated