BARD Dynamic Tip Steerable Medical Device Recall Due to Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable devices due to incomplete seals on the sterile product. The recall affects 427 units distributed nationwide and in Israel and Canada.
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 medical device recall. Incomplete seals on a sterile device create a risk of contamination or loss of sterility, which could harm users. No illnesses or injuries are reported in the source text, but the hazard is concrete rather than theoretical.
Plain-English summary
Stryker Sustainability Solutions is recalling the BARD Dynamic Tip Steerable, Product Number 6DYNTP001. The recall was initiated because some units have incomplete seals on the sterile product, which could compromise the sterility of the device.
The affected product includes 427 units with UDI 00885825005528 and multiple lot numbers. These units were distributed throughout the United States, Israel, and Canada.
Consumers who have received or are using this product should contact Stryker Sustainability Solutions for instructions on how to proceed. Healthcare providers and patients should not use affected units to ensure product safety and integrity.
The recalled product
- Product
- BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
- Manufacturer
- Stryker Sustainability Solutions
- Category
- Medical Device — Sterile Device
- Hazard
- sterility-compromise
- incomplete-seal
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 00885825005528
- Lot Numbers: 3495675
- 4117216
- 4330131
- 4471121
- 4553575
- 4630179
- 4768595
- 4821705
- 4954755
- 5043512
- 3684287
- 4129638
- 4334639
- 4471122
- 4554838
- 4630180
- 4773075
- 4821706
- 4954759
Distribution
Distributed nationwide across the United States.