510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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

59,476 records, page 926 of 1190
FDA device recalls, page 926 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1357-2010Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line...Abbott MedicalFPA
Z-1356-2010Lifeshield, latex-free Primary I.V. Pump set with Distal Microbore Patient Line and...Abbott MedicalFPA
Z-1355-2010Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and...Abbott MedicalFPA
Z-1354-2010Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and...Abbott MedicalFPA
Z-1353-2010Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line...Abbott MedicalFPA
Z-1352-2010Lifeshield, latex-free, Primary I.V. Pump Set with distal microbore patient line and...Abbott MedicalFPA
Z-1351-2010Latex-free, Primary I.V. Pump Set with distal microbore patient line and gravity flow...Abbott MedicalFPA
Z-1350-2010Latex-free, Primary I.V. Pump Set, convertible pin, 105 inch with 2 injection sites, 15...Abbott MedicalFPA
Z-1349-2010Lifeshield, latex-free, Primary I.V. PLUMSET, convertible pin, 103 inch with backcheck...Abbott MedicalFPA
Z-1348-2010Lifeshield, latex-free, Primary I.V. PLUMSET, convertible pin, 113 inch with 2...Abbott MedicalFPA
Z-1347-2010Lifeshield, Primary I.V. Filter Set, yellow key slide clamp, backcheck valve, 2 CLAVE...Abbott MedicalFPA
Z-1346-2010Lifeshield, Primary I.V. Filter Set, yellow key slide clamp, backcheck valve, 2 CLAVE...Abbott MedicalFPA
Z-1345-2010Latex-free, Nitroglycerin Primary I.V. Pump Set, convertible pin, 107 inch with...Abbott MedicalFPA
Z-1344-2010ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Purple...Abbott MedicalFPA
Z-1343-2010ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Green...Abbott MedicalFPA
Z-1342-2010ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Orange...Abbott MedicalFPA
Z-1341-2010Latex-free. Midlength Secondary I.V. Set, convertible pin, 40 inch with extension hook...Abbott MedicalFPA
Z-1340-2010Latex-free, Nitroglycerin, Midlength Secondary I.V. Pump Set, convertible pin, 40 inch...Abbott MedicalFPA
Z-1339-2010Lifeshield, latex-free, HEMA, GEMSTAR, Y-Type Blood Pump Set, nonvented, 110 inch with...Abbott MedicalFPA
Z-1338-2010Lifeshield, latex, free, GEMSTAR Primary Piggyback Pump Set-SL, convertible pin, attached...Abbott MedicalFPA
Z-1337-2010Lifeshield, latex-free, MICRO-DRIP, SOLUSET, GEMSTAR 150 ml Burette Pump Set-OL...Abbott MedicalFPA
Z-1336-2010Lifeshield, CVP Manometer, latex-free, Y-type primary IV set, nonvented, 86.5 inch with...Abbott MedicalFPA
Z-1335-2010Lifeshield, latex-free 210 Micron Filter, Y-Type Blood Set, yellow key slide clamp, CLAVE...Abbott MedicalFPA
Z-1334-2010Lifeshield, latex-free 170 Micron Filter, Y-Type Blood Set, yellow key slide clamp, CLAVE...Abbott MedicalFPA
Z-1333-2010Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 77 inch with 2 CLAVE ports...Abbott MedicalFPA
Z-1332-2010Lifeshield, latex-free, 150 mL Burette Set, nonvented, 117 inch with pre-pierced...Abbott MedicalFPA
Z-1331-2010Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 77.5 inch with 2 pre-pierced...Abbott MedicalFPA
Z-1330-2010Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 77 inch with capped port and...Abbott MedicalFPA
Z-1329-2010Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 100 inch with 2 pre-pierced...Abbott MedicalFPA
Z-1328-2010Lifeshield, latex-free 150 mL Burette IV Set, yellow key slide clamp, microdrip, CLAVE...Abbott MedicalFPA
Z-1327-2010Lifeshield, latex-free 100mL Burette Set, convertible pin, 77 inch with 2 pre-pierced...Abbott MedicalFPA
Z-1063-2010Symbiq Pump Set, detachable, convertible pin piggyback w/backcheck valve, 3 prepierced...Abbott MedicalFPA
Z-1062-2010Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, Latex-Free...Abbott MedicalFPA
Z-1061-2010Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, Latex-Free, non-DEHP, 20 drops/mL...Abbott MedicalFPA
Z-1060-2010Primary Symbiq Set, Latex-Free piggyback with backcheck valve, 3 prepierced Y-sites, 106...Abbott MedicalFPA
Z-1059-2010Primary Symbiq Set, Latex-Free, Polyethylene-Lined tubing, piggyback with backcheck...Abbott MedicalFPA
Z-1058-2010Latex-Free Primary Symbiq Pump Set, piggyback with backcheck valve, 2 CLAVE Y-sites, 105...Abbott MedicalFPA
Z-1057-2010Primary Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced sites, 105 inch...Abbott MedicalFPA
Z-1056-2010Primary Latex-Free Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced Y-sites...Abbott MedicalFPA
Z-0718-2010Outlook Pump Y Type Blood Set with 170um Blood Filter, Injection Site, Spin Lock...B Braun Medical IncFPA
Z-0717-2010Outlook Pump IV Set for Epidural Admin w/Universal Spike, Microbore Tubing, Spin Lock...B Braun Medical IncFPA
Z-0716-2010Outlook Pump Nitroglycerin Set w/Universal Spike & Spin Lock Connector, 135 inB Braun Medical IncFPA
Z-0715-2010Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Inj Sites, Spin...B Braun Medical IncFPA
Z-0714-2010Outlook Pump IV Set with Universal Spike, Pressure Limited Check Valve, 3 Inj Sites, Spin...B Braun Medical IncFPA
Z-0713-2010Outlook Pump IV Set w/Universal Spike, Injection Site & Spin Lock Connector, 132 inB Braun Medical IncFPA
Z-0712-2010Outlook Pump Add On Set for Epidural Administration w/Microbore tubing & Sliding Spin...B Braun Medical IncFPA
Z-0711-2010Outlook Pump Syringe Add On Set w/Microbore Tubing, Injection Site, Spin Lock Connector...B Braun Medical IncFPA
Z-0710-2010Outlook Pump Add On Set with Injection Site & Spin Lock Connector, 90 inB Braun Medical IncFPA
Z-0709-2010Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj Sites, Spin Lock Con & Pressure...B Braun Medical IncFPA
Z-0708-2010Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Ultrasite...B Braun Medical IncFPA