United StatesMultiple reprocessed electrophysiology catheters from Stryker Sustainability Solutions — including BARD Dynamic Deca Steerable (product number 201101) and 25 other models identified by product numbers, UDI 00885825003845 and numerous lot numbers — are affected. They were recalled due to incomplete seals on sterile product; affected units were distributed in the United States, Israel, and Canada.
What's being recalled
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
And 11 more products.
Recalling firm: Stryker Sustainability Solutions, Tempe, AZ, United States.
How to identify it
UDI 00885825003845, Lot Numbers: 3021656, 4158368, 4305347, 4457640, 4560383, 4660045, 4815497, 4881594, 4987017, 5032942, 3107869, 4160047, 4305348, 4457904, 4562726, 4660052, 4815499, 4881600, 4987018, 5033611, 3171909, 4160048, 4305500, 4460044, 4565142, 4662242, 4816776, 4881613, 4987355, 5033612, 3197667, 4160049, 4305998, 4461505, 4565897, 4662243, 4816890, 4881615, 4989058, 5033626, 3231845, 4160051, 4307998, 4461555, 4565899, 4662546, 4816891, 4881618, 4989060, 5033627, 3241416, 4160053, 4308004, 4461558, 4565901, 4662547, 4816898, 4882585, 4990629, 5033628, 3248595, 4161235, 4309667, 4461560, 4565902, 4662549, 4817898, 4883073, 4990630, 5033673, 3254499, 4161239, 4311144, 4461580, 4565903, 4662550, 4818896, 4883093, 4990647, 5033679, 3259151, 4162340, 4311159, 4461628, 4565904, 4662551, 4818897, 4883094, 4990648, 5034212, 3272697, 4163622, 4311161, 4461639, 4565905, 4662552, 4818901, 4883096, 4990649, 5034213, 3304525, 4163719, 4312042, 4461640, 4565906, 4662560, 4820191, 4883336, 4990650, 5034214, 3350827, 4164530, 4312217, 4461893, 4565907, 4663275, 4820282, 4883337, 4990653, 5034215, 3370014, 4166100, 4312218, 4461894, 4565908, 4663469, 4820283, 4883338, 4990796, 5034796, 3371667, 4167414, 4312220, 4462110, 4565909, 4664191, 4820499, 4883339, 4990798, 5035334, 3377338, 4167415, 4312223, 4462871, 4565910, 4664193, 4820501, 4883807, 4990799, 5035489, 3403757, 4167923, 4314048, 4462872, 4565911, 4664196, 4820502, 4883808, 4990856, 5037613, 3404142, 4167925, 4314189, 4462873, 4566255, 4665171, 4820597, 4883809, 4990857, 5037831, 3406269, 4167928, 4314374, 4462874, 4566256, 4670446, 4822107, 4883810, 4990858, 5038073, 3439491, 4167929, 4317696, 4462875, 4566257, 4670448, 4822139, 4884751, 4990859, 5038074, 3468445, 4167937, 4318005, 4462876, 4566258, 4672131, 4822143, 4890818, 4990860, 5038075, 3556073, 4168753, 4319656, 4462878, 4566259, 4673453, 4822144, 4890819, 4992052, 5038076, 3591743, 4169893, 4319681, 4463037, 4566260, 4676972, 4822145, 4890820…
The hazard
Incomplete seals on sterile product
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide and the countries of Israel and Canada.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada