Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200344) due to incomplete seals on sterile product packaging that could compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device with a defect (incomplete seals) that could allow contamination. While no illnesses or injuries are reported in the source, the risk-of-harm from a compromised sterile barrier on an invasive catheter meets the "High" threshold for medical devices where injury has not yet been reported.
Plain-English summary
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200344) distributed nationwide in the US, as well as in Israel and Canada. The recalled catheters have incomplete seals on sterile product packaging, which could allow contamination to enter the sterile product.
The defect affects 28 units with specific lot numbers identified in the recall. The incomplete seals compromise the sterility assurance of the product, potentially exposing patients to contamination during use.
Customers who have received this product should contact Stryker Sustainability Solutions for instructions on affected units. Healthcare providers should check their inventory for the listed lot numbers and quarantine any matching units until further guidance is provided.
The recalled product
- Product
- BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- incomplete-seal
- sterility-compromise
- contamination-risk
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 00885825003135
- Lot Numbers: 2268964
- 2687510
- 3173767
- 3269330
- 3379246
- 4398753
- 4876242
- 2501717
- 2878890
- 3231930
- 3336473
- 3394078
- 4780878
- 4876243
- 2533915
- 3137651
- 3266358
- 3361335
- 3454810
Distribution
Distributed nationwide across the United States.