Fios First Entry recall
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in…
Why was Fios First Entry recalled?
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
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?
Lot Codes for Model CTF03: 314326, 362394, 365229, 401076, 413450, 420581, 420607, 420609, 428106, 428114, 429863, 429866, 456224, 456242, 459592, 459597, 459617, 459954, 461862, 464282, 466767, 467197, 467198, 467350, 467413, 468306, 468471, 468497, 468498, 468941, 469533, 469538, 469539, 469956, 469960, 470614, 471039, 471048, 471060, 471126, 471721, 471725, 471789, 471895, 471911, 471917, 473040, 473280, 473936, 474004, 474035, 474061, 474338, 474340, 474381, 474482, 474487, 474493, 474940, 475171, 475429, 475439, 476151, 476152, 476155, 476191, 476200, 476259, 476277, 476751, 476985, 476989, 477172, 477304, 477306, 477865, 478264, 478268, 478668, 479437, 479821, 480663, 480684, 481109, 481615, 481808, 481951, 481968, 481977, 482137, 482216, 482607, 482630, 482664, 482669, 482672, 482692, 482885, 482956, 482959, 483508, 483554, 483908, 483911, 483918, 483953, 483963, 485020, 485218, 485502, 485581, 485671, 485724, 486058, 486143, 486209, 486394, 486800, 486853, 486855, 487203, 488297, 488356, 488601, 489255, 489701, 489717, 489745, 489960, 490084, 490101, 490864, 490887, 491256, 491267, 491500, 600329, 600462, 600929, 601012, 601786, 601925, 601945, 602261, 1700377, 1742132, 1750017, 1752379, 1825271, 1831415, 1838630, 1854074, 1873579, 1924143, 1940389, 1993186, 1995046, 2026174, 2027905, 2099505, 2128128, 2141295, 2171826, 2175866, 2201812, 2202067, 2207903, 2222389, 2256944, 2279303, 2958995, 2959099, 2959393, 2967775, 2967953, 2967969, 2968684, 2971490, 2972179, 2972432, 2972523, 2974255, 2974595, 2974645, 2974873, 2976787, 2977905, 2978075, 2978215, 2979090, 2979438, 2980071, 2980305, 2983205, 2983527, 2985634, 2985741, 2985993, 2986317, 2986329, 2987002, 2989753, 2989851, 2990255, 2990970, 2991547, 2991801, 2994252, 2994268, 2996250, 2996278, 2998784, 3000843, 3003011, 3003146, 3003534, 3006299, 3006309, 3007744, 3017809, 3017897, 3019141, 3020340, 3020726, 3021288, 3022515, 3022527, 3025882, 3032891, 3032917, 3033615, 3033627, 3035146, 3035151, 3035575, 3035581, 3052047, 3052863, 3053399, 3053458, 3059535, 3059906, 3063793, 3064331, 3064527, 3065459, 3065519, 3069524, 3074847, 3074852, 3075234, 3075247, 3076850, 3078395, 3078400, 3079634, 3080357, 3080361, 3080763, 3081497, 3083566, 3089890, 3089900, 3092020, 3092255, 3092264, 3093953, 3094667, 3094985, 3094992, 3095005, 3095014, 3099954, 3099965, 3100547, 3102846, 3102851, 3103176, 3103343, 3103358, 3108380, 3110878, 3111384, 3111795, 3113296, 3114007, 3114011, 3115286, 3116045, 3116050, 3118392, 3118407, 3120168, 3120650, 3120716, 3122269, 3122276, 3126999, 3127514, 3129755, 3133588, 3135549, 3138676, 3138682, 3141395, 3142937, 3145355, 3145364, 3149085, 3149658, 3152031, 3152110, 3154888, 3156973, 3160045, 3161763, 3162732, 3165164, 3165571, 3168278, 3168767, 3170546, 3170551, 3172878, 3172884, 3175161, 3175541, 3183829, 3185529, 3188163, 3190831, 3194023, 3198793, 3201657, 3203692, 3206793, 3209459, 3213698, 3216157, 3219175, 3223419, 3227058, 3229265, 3231929, 3242541, 3242556, 3242692, 3251050, 3251066, 3251078, 3253575, 3253581, 3257175, 3257524, 3258813, 3262050, 3262499, 3265301, 3266817, 3267267, 3267280, 3267527, 3269037, 3269085, 3270954, 3271670, 3275447, 3275452, 3278598, 3279897, 3282553, 3284583, 3284596, 3288082, 3288789, 3289234, 3290049 Lot Codes for CTF73: 3180165, 3181358, 3181959, 3183394, 3183432, 3185966, 3186537, 3188429, 3189243, 3192067, 3193604, 3194941, 3194994, 3198107, 3198239, 3201661, 3202726, 3204497, 3204506, 3207156, 3207160, 3210263, 3210271, 3214365, 3214377, 3217385, 3217407, 3220601, 3220849, 3224735, 3224742, 3227313, 3227321, 3229541, 3229556, 3231972, 3231986, 3233272, 3235415, 3235685, 3237169, 3237447, 3238117, 3238439, 3248221, 3274181, 3274524, 3274530, 3274936, 3275097, 3277283, 3277296, 3277502, 3277600,, 3278329, 3280207, 3280211, 3280224, 3291838
- Product
- Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in…
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 147,351
- Distribution
- Distributed Nationwide including Puerto Rico.
- Recall date
- July 1, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)