510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,528 records, page 465 of 1191
FDA device recalls, page 465 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2013-2018Class II0.2 Micron Flat Epidural Filter; Product Code: EF-05500Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-2012-2018Class IITheraCath(R) Epidural Catheter; Product Code: EC-05000Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-2011-2018Class IISpring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018Arrow International LLC (subsidiary of Teleflex Incorporated)DYB
Z-2010-2018Class IIClear Fenestrated Drape with Adhesive; Product Code: CD-00001Arrow International LLC (subsidiary of Teleflex Incorporated)KKX
Z-2009-2018Class II8Fr. Catheter Clamp with Fastener; Product Code: CC-00008Arrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-2008-2018Class II7Fr. Catheter Clamp with Fastener; Product Code: CC-00007Arrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-2007-2018Class II5Fr. Catheter Clamp with Fastener; Product Code: CC-00005Arrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-2006-2018Class II4Fr. Catheter Clamp with Fastener; Product Code: CC-00004Arrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-2005-2018Class IIARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-2004-2018Class IIMulti-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-2003-2018Class IIMulti-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-2002-2018Class IITwo-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-2001-2018Class IIDouble-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-2000-2018Class IIARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1999-2018Class IIMulti-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1998-2018Class IIMulti-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1997-2018Class IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1996-2018Class IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1995-2018Class IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1994-2018Class IIARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit; Product Codes...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1993-2018Class IIPressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1992-2018Class IIARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1AArrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1991-2018Class IIPressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1990-2018Class IIPressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1989-2018Class IIARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1988-2018Class IIPressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1987-2018Class IIMulti-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1986-2018Class IIPercutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis...Arrow International LLC (subsidiary of Teleflex Incorporated)DYB
Z-1985-2018Class IIARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1984-2018Class IISingle-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R)...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1983-2018Class IIMAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1982-2018Class IIARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr...Arrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-1981-2018Class IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1980-2018Class IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1979-2018Class IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-1978-2018Class IITwo-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps...Arrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-1977-2018Class IIPercutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps...Arrow International LLC (subsidiary of Teleflex Incorporated)DYB
Z-1976-2018Class IIPercutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with...Arrow International LLC (subsidiary of Teleflex Incorporated)DYB
Z-1975-2018Class IIArrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and...Arrow International LLC (subsidiary of Teleflex Incorporated)DYB
Z-2260-2018Class IIThe BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood...Becton Dickinson & CoJKA
Z-2259-2018Class IIThe BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood...Becton Dickinson & CoJKA
Z-2258-2018Class IIThe BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood...Becton Dickinson & CoJKA
Z-1974-2018Class IISingle-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps...Arrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-1973-2018Class IIRadial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HFArrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-1972-2018Class IIRadial Artery Catheterization Kit with Sharps Safety Features; Product Codes...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1971-2018Class IIArterial Catheterization Kit; Product Codes: ASK-04020-DHArrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1970-2018Class IIRadial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1969-2018Class IIArterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1968-2018Class IIRadial Arterial Access Kit; Product Code: ASK-04001-BID2Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1967-2018Class IIMaximal Barrier Drape; Product Code: ASK-04000-HMCArrow International LLC (subsidiary of Teleflex Incorporated)DQY