Stryker Sustainability Solutions: BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Stryker Sustainability Solutions
- Product
- BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Reason / hazard
- Incomplete seals on sterile product
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide and the countries of Israel and Canada.
- Recall initiated
- 2026-04-10
- Code info
- UDI 00885825003739, Lot Numbers 4573219, 4869696, 4992244, 4999900, 5025367, 5038410, 5085389, 4804556, 4971805, 4992245, 4999902, 5032111, 5043783, 4804558, 4971806, 4992246, 5012684, 5032112, 5043784, 4809474, 4990763, 4992247, 5012708, 5032113, 5043785, 4829451, 4990764, 4993772, 5012709, 5033926, 5043787, 4835199, 4990769, 4997966, 5012711, 5033927, 5056579, 4841812, 4992243, 4998135, 5012726, 5033928, 5056828.
- Product quantity
- 44 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Tempe
- State
- AZ
- Country
- United States
- Event id
- 98708
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