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-2393-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-N212), REF 413061, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2392-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-N211), REF 413043, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2391-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-N209), REF 412938, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2390-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-N204), REF 412865, 20 cards per carton. . | bioMerieux, Inc. | N/A | |
| Z-2389-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-N203), REF 412864, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2388-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-N202), REF 412863, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2387-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-N201), REF 412862, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2386-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-N195), REF412609, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2385-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN65), REF 412608, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2384-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-N194), REF 412605, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2383-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-N193), REF 412604, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2382-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-N190), REF 412548, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2381-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P621), REF 412533, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2380-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton. | bioMerieux, Inc. | LON | |
| Z-2379-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN48), REF 412090, 20 cards per carton. | bioMerieux, Inc. | LON | |
| Z-2378-2017 | Class II | VITEK 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton. | bioMerieux, Inc. | NGZ | |
| Z-2377-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P619), REF 411944, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2376-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P618), REF 410806, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2375-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-GP71), REF 410750, 20 cards per carton. | bioMerieux, Inc. | LON | |
| Z-2374-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-XN04), REF 410401, 20 cards per carton. | bioMerieux, Inc. | LON | |
| Z-2373-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P616), REF 410223, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2372-2017 | Class II | VITEK 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per... | bioMerieux, Inc. | LON | |
| Z-2371-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P613), REF 410027, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2370-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-XN01), REF 410025, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2369-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P612), REF 22359, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2368-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P608), REF 22336, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2367-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards per carton. | bioMerieux, Inc. | LON | |
| Z-2366-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN38), REF 22331, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2365-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P606), REF 22330, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2364-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P605), REF 22325 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2363-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P603), REF 22320, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2362-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2361-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-GP69), REF 22304, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2119-2017 | Class I | 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to... | EBI Patient Care, Inc. | LOE | |
| Z-2360-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P597), REF 22298, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2359-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P592), REF 22287, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2358-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P586), REF 22276, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2357-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-N102), REF 22258, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2356-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P584), REF 22252, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2355-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P580), REF 22233, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2354-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-GP68), REF 22231, 20 cards per carton. | bioMerieux, Inc. | LON | |
| Z-2353-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton. | bioMerieux, Inc. | LON | |
| Z-2352-2017 | Class II | VITEK 2 Gram Positive Susceptibility card (AST-P577), REF 22218, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2351-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton. | bioMerieux, Inc. | LON | |
| Z-2350-2017 | Class II | VITEK 2 Fungal Susceptibility card (AST-YS01), REF 22108, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2349-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per carton. | bioMerieux, Inc. | LON | |
| Z-2348-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN13), REF 22095, 20 cards per carton. | bioMerieux, Inc. | LON | |
| Z-2347-2017 | Class II | VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton. | bioMerieux, Inc. | LON | |
| Z-2346-2017 | Class II | VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per... | bioMerieux, Inc. | JSP | |
| Z-2345-2017 | Class II | VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per... | bioMerieux, Inc. | JST |