FDAClass IIJuly 1, 2015

Cannula and Seal recall

Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in…

Why was Cannula and Seal 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 CTS02: 362394, 420607, 428114, 429863, 459230, 459592, 459597, 459960, 459990, 461060, 461694, 465212, 466767, 467172, 468490, 469533, 469538, 469539, 469540, 469955, 469956, 469963, 470140, 470614, 471021, 471067, 471079, 471092, 471102, 471109, 471126, 471131, 471135, 471895, 472125, 473040, 473260, 473293, 474004, 474015, 474035, 474324, 474338, 474340, 474476, 475171, 475465, 475617, 476151, 476173, 476200, 476259, 476272, 476277, 476989, 477306, 477315, 478318, 478338, 478339 478668, 479821, 479828, 480663, 480677, 480682, 480684, 481607, 481808, 481951, 481960, 481968, 483554, 483918, 483922, 483926, 483953, 483963 484011, 484027, 484032, 485218, 485511, 485557, 485567, 485591, 485622, 485656, 485660, 486107, 486138, 486143, 486209, 486253, 486800, 487210, 489255, 489651, 489704, 489738, 489745, 489957, 489958, 489962, 489979, 490076, 490086, 490864, 491163, 491256, 600325, 600929, 601012, 601925, 601982, 603277, 609051, 1786420, 1825271, 1891296, 2027905, 2163528, 2171826, 2175866, 2208579, 2222389, 2271560, 2279303, 2315316, 2954381, 2954628, 2954637, 2954778, 2957110, 2957134, 2958233, 2958246, 2969207, 2969426, 2969662, 2971689, 2972095, 2973798, 2974887, 2975148, 2975549, 2978669, 2978885, 2978892, 2980457, 2980834, 2983706, 2984021, 2984032, 2987284, 2987526, 2987896, 2989769, 2991263, 2993610, 2994626, 2995924, 2999738, 3002060, 3005909, 3018096, 3018650, 3020166, 3020757, 3021385, 3024073, 3026984, 3028690, 3028730, 3031396, 3031995, 3034204, 3037138, 3039352, 3040004, 3042988, 3043284, 3047352, 3047368, 3052859, 3054151, 3056633, 3056646, 3058219, 3059896, 3061761, 3065444, 3067448, 3070389, 3070391, 3072732, 3072745, 3075949, 3078655, 3081506, 3082044, 3083550, 3083597, 3085192, 3086485, 3086492, 3089009, 3091458, 3093279, 3096393, 3099949, 3184750, 3185474, 3186015, 3187181, 3187989, 3190002, 3190820, 3192550, 3193913, 3195683, 3198508, 3200845, 3201425, 3203415, 3204394, 3206304, 3207173, 3209437, 3210285, 3212965, 3214734, 3215952, 3217550, 3222005, 3224973, 3226077, 3231623, 3232298, 3234278, 3235296, 3286925, 3287266, 3290012, 3291855, 3291864 Lot Codes for Model CTS22: 362394, 365226, 419887, 429863, 459960, 469533, 469538, 469539, 469540, 471038, 471895, 472125, 475171, 476259, 481709, 481951, 481965, 481971, 483578, 483963, 484002, 484032, 485506, 486148, 486800, 487212, 487954, 489255, 489957, 490153, 603981, 1742132, 2171826, 2271563, 2295535, 3180274, 3180699, 3180702, 3185379, 3187970, 3190574, 3193160, 3195339, 3200866, 3209060, 3212544, 3215947, 3218572, 3221995, 3225575, 3226065, 3233621, 3288568, 3288575

Product
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. 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)
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