Sterile Handpiece Sheaths recall: Sterility Concern
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units --- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 ---
Why was Sterile Handpiece Sheaths recalled?
For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 1540070, 15450384, 15500476, 16020037, 16150086, 16260128, 16360182, 16450236, 15320037, 15450385, 15500477, 16020038, 16150087, 16260129, 16360183, 16450237, 15330049, 15450386, 15500478, 16020039, 16150088, 16260130, 16360184, 16450238, 15330052, 15450387, 15500479, 16020040, 16150089, 16260131, 16360185, 16450239, 15330053, 15450388, 15500480, 16040041, 16150090, 16260132, 16360186, 16450240, 15340074, 15450389, 15500481, 16040042, 16180091, 16260133, 16360187, 16460241, 15350086, 15450390, 15500482, 16040043, 16180091, 16260134, 16360188, 16460244, 15360096, 15450391, 15500483, 16040044, 16180092, 16260135, 16360189, 16460246, 15360105, 15450392, 15500484, 16040045, 16180092, 16260136, 16360190, 16460248, 15360108, 15450393, 15500485, 16040046, 16180093, 16260137, 16410191, 16460249, 15400254, 15460398, 15500486, 16040047, 16180094, 16260138, 16410192, 16460250, 15400255, 15480434, 15500487, 16040048, 16180095, 16260139, 16410193, 16500266, 15400256, 15480435, 15500488, 16040049, 16180096, 16260140, 16410194, 16500267, 15400257, 15480436, 15500489, 16040050, 16180097, 16260141, 16410195, 16500270, 15400258, 15480437, 15500490, 16040051, 16180098, 16260142, 16410196, 16500271, 15400259, 15480438, 15500491, 16040052, 16180099, 16260143, 16410197, 16500272, 15400260, 15480439, 15500492, 16040053, 16180100, 16260144, 16410198, 16500274, 15400261, 15480440, 15500493, 16040054, 16180101, 16260145, 16410199, 16500275, 15400262, 15480441, 16010001, 16040055, 16180102, 16260146, 16410200, 16500277, 15400263, 15480442, 16010002, 16040056, 16180103, 16260147, 16420201, 16500278, 15400264, 15480443, 16010003, 16040056, 16180104, 16260148, 16420202, 16500279, 15400265, 15480444, 16010004, 16040057, 16180105, 16260149, 16420203, 16500280, 15400266, 15480445, 16010005, 16040057, 16180106, 16260150, 16420204, 154000269, 15400267, 15480446, 16010006, 16040058, 16180107, 16260151, 16420205, 15400268, 15480447, 16010007, 16040058, 16180108, 16260152, 16420206, 15400270, 15480448, 16010008, 16040059, 16180109, 16260153, 16420207, 15400271, 15480449, 16010009, 16040059, 16180110, 16260154, 16420208, 15400272, 15480450, 16010010, 16040060, 16200111, 16260155, 16420209, 15400273, 15480451, 16010011, 16040060, 16200112, 16260156, 16420210, 15400274, 15480452, 16010012, 16040061, 16200113, 16260157, 16430211, 15400275, 15480453, 16010013, 16040062, 16200114, 16260158, 16430212, 15400276, 15480453, 16010014, 16040063, 16200115, 16260159, 16430213, 15400277, 15490454, 16010015, 16040064, 16200116, 16260160, 16430214, 15400278, 15490455, 16010016, 16040065, 16200117, 16260161, 16430215, 15400279, 15490456, 16010017, 16040066, 16200118, 16260162, 16430216, 15400280, 15490457, 16010018, 16040067, 16200119, 16260163, 16430217, 15400281, 15490458, 16010019, 16040068, 16200120, 16260164, 16430218, 15400282, 15490459, 16010020, 16040069, 16220121, 16260165, 16430219, 15400283, 15490460, 16020021, 16040070, 16220122, 16260166, 16430220, 15400284, 15490461, 16020022, 16040071, 16220123, 16260167, 16430221, 15400285, 15490462, 16020023, 16040072, 16220124, 16260168, 16430222, 15400286, 15490463, 16020024, 16040073, 16220125, 16260169, 16430223, 15400287, 15490464, 16020025, 16040074, 16220126, 16260170, 16430224, 15400288, 15490465, 16020026, 16040075, 16220127, 16360171, 16430225, 15410331, 15490466, 16020027, 16040076, 16220128, 16360172, 16430226, 15450374, 15490467, 16020028, 16040077, 16220129, 16360173, 16430227, 15450375, 15490468, 16020029, 16040078, 16220130, 16360174, 16430228, 15450376, 15490469, 16020030, 16040079, 16260121, 16360175, 16430229, 15450377, 15490470, 16020031, 16040080, 16260122, 16360176, 16430230, 15450378, 15490471, 16020032, 16150081, 16260123, 16360177, 16450231, 15450379, 15490472, 16020033, 16150082, 16260124, 16360178, 16450232, 15450380, 15490473, 16020034, 16150083, 16260125, 16360179, 16450233, 15450381, 15500474, 16020035, 16150084, 16260126, 16360180, 16450234, 15450383, 15500475, 16020036, 16150085, 16260127, 16360181, 16450235.
- Product
- Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units --- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 ---
- Recalling firm
- ConMed Corporation
- Quantity
- N/A
- Distribution
- Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.
- Recall date
- April 19, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)