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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-2277-2017 | Class II | Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2276-2017 | Class II | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2275-2017 | Class II | Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2274-2017 | Class II | Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2273-2017 | Class II | Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2272-2017 | Class II | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2271-2017 | Class II | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2270-2017 | Class II | ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit. The large-bore multiple-lumen catheter... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2269-2017 | Class II | Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2268-2017 | Class II | Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2267-2017 | Class II | Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2266-2017 | Class II | Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2265-2017 | Class II | ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2264-2017 | Class II | ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2263-2017 | Class II | ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2262-2017 | Class II | Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2261-2017 | Class II | Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2260-2017 | Class II | Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2259-2017 | Class II | MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2258-2017 | Class II | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2257-2017 | Class II | Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2256-2017 | Class II | Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2255-2017 | Class II | ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2254-2017 | Class II | ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2253-2017 | Class II | MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1921-2017 | Class II | ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID... | ROHO, Inc. | KIC | |
| Z-1823-2017 | Class II | Tapered SwissPlus Implant System, Model No. SPB10 | ZimVie US Corp LLC | DZE | |
| Z-3069-2017 | Class II | DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models... | Medtronic Neuromodulation | MHY | |
| Z-1879-2017 | Class II | Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2072-2017 | Class II | GIZA Vertebral Body Replacement | Eden Spine Europe SA | MQP | |
| Z-1767-2017 | Class II | CADD Administration Set, 21-7339-24, Rx Only, Sterile EO. | Abbott Medical | FPA | |
| Z-1801-2017 | Class II | VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is... | bioMerieux, Inc. | CHP | |
| Z-1746-2017 | Class II | BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm... | Becton Dickinson & Co | JKA | |
| Z-1800-2017 | Class II | Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1799-2017 | Class II | Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1798-2017 | Class II | Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1797-2017 | Class II | PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1796-2017 | Class II | Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1795-2017 | Class II | Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1794-2017 | Class II | Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1793-2017 | Class II | Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1792-2017 | Class II | Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1791-2017 | Class II | Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1790-2017 | Class II | Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1789-2017 | Class II | ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1788-2017 | Class II | Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1787-2017 | Class II | Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1786-2017 | Class II | Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1785-2017 | Class II | Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1784-2017 | Class II | Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient... | Windstone Medical Packaging, Inc. | FSY |