BARD Dynamic XT Deca Steerable electrophysiology catheter Class II recall
Stryker Sustainability Solutions is recalling 90 units of the BARD Dynamic XT Deca Steerable electrophysiology catheter due to incomplete seals on the sterile product.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device with a defect (incomplete seals) that creates a risk of infection. Class II recalls with risk-of-harm products where the hazard involves sterility compromise of invasive medical devices meet the Severe threshold.
Plain-English summary
Stryker Sustainability Solutions is recalling 90 units of the BARD Dynamic XT Deca Steerable, Product Number 201102, a reprocessed electrophysiology catheter. The recall affects product with UDI 00885825003869 and the 80 specific lot numbers listed by the FDA. The issue identified is incomplete seals on the sterile product.
The recalled units were distributed nationwide in the United States and to the countries of Israel and Canada. Incomplete seals on a sterile medical device could compromise sterility and create a potential risk of infection.
Customers who have received affected units should contact Stryker Sustainability Solutions. Healthcare facilities should identify and quarantine affected inventory by lot number and cease use of the recalled product.
The recalled product
- Product
- BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 90
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI 00885825003869
- Lot Numbers: 3975235
- 4253785
- 4277547
- 4297459
- 4656095
- 4818154
- 4972266
- 4065815
- 4253786
- 4277548
- 4297460
- 4656096
- 4818155
- 5032390
- 4180953
- 4253791
- 4296975
- 4363237
- 4717623
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by Stryker Sustainability Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 26 products in this recall →Related recalls
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