FDAClass IIMarch 14, 2018

Stryker Sustainability Solutions Reprocessed BW Lasso recall

Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515…

Why was Stryker Sustainability Solutions Reprocessed BW Lasso recalled?

An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.

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 2451387, 2484264, 2484471, 2486823, 2487380, 2488350, 2490592, 2490605, 2492930, 2494064, 2494067, 2495242, 2495335, 2495337, 2495339, 2500403, 2500911, 2510524, 2518512, 2523848, 2523849, 2523851, 2525678, 2528071, 2534854, 2534856, 2608429, 2609031, 2609102, 2609105, 2609106, 2609107, 2609985, 2610794, 2610802, 2614613, 2614847, 2614909, 2615094, 2615098, 2615099, 2615319, 2615646, 2615712, 2615722, 2615725, 2615937, 2615938, 2615940, 2615943, 2615952, 2615966, 2616087, 2616088, 2616089, 2616090, 2616212, 2617794, 2617920, 2617987, 2617999, 2618010, 2618258, 2618832, 2618837, 2618881, 2618884, 2618990, 2618992, 2618993, 2619615, 2619742, 2619744, 2619827, 2620937, 2620942, 2620945, 2621283, 2621384, 2621385, 2621387, 2621424, 2621425, 2621847, 2621860, 2621880, 2623972, 2623974, 2624006, 2624010, 2624113, 2624138, 2625427, 2625536, 2625550, 2625623, 2625625, 2626330, 2626348, 2626929, 2626966, 2626988, 2627596, 2627946, 2627948, 2627949, 2629162, 2629164, 2630084, 2630085, 2630087, 2630351, 2631186, 2631188, 2631189, 2631191, 2631680, 2632641, 2633968, 2634008, 2634252, 2634271, 2634596, 2634709, 2634815, 2634836, 2635075, 2635077, 2635342, 2635343, 2635867, 2635873, 2636658, 2636759, 2636906, 2636986, 2637009, 2637022, 2637023, 2637233, 2637234, 2637237, 2637239, 2637257, 2637308, 2637495, 2637497, 2640103, 2640106, 2640107, 2640118, 2640119, 2642853, 2643222, 2643426, 2643432, 2646002, 2647122, 2669947, 2693960, 2696255, 2705129, 2708915, 2708916, 2712736, 2712756, 2713556, 2713593, 2713595, and 2713596.

Product
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515…
Recalling firm
Stryker Sustainability Solutions
Quantity
170 devices
Distribution
USA (nationwide) Distribution was made to medical facilities in AZ, CA, CT, FL, GA, IL, KS, LA, MN, MO, OH, PA, TX, VT, WA, and Wi. Foreign distribution was made to Canada.
Recall date
March 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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