Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic Deca Steerable reprocessed electrophysiology catheters (Product Number 201101) distributed nationwide and in Israel and Canada due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 high-risk hazard (compromised sterility that could affect device safety), and no reported illnesses or injuries have been stated in the source text. Per the rubric, a risk-of-harm product with sterility compromised falls into the High category.
Plain-English summary
Stryker Sustainability Solutions is recalling BARD Dynamic Deca Steerable reprocessed electrophysiology catheters, Product Number 201101, due to incomplete seals on the sterile product. A total of 3,063 units were distributed to the United States, Israel, and Canada. The affected devices are identified by UDI 00885825003845 and multiple lot numbers listed in the recall notice.
Incomplete seals on the sterile packaging may compromise the sterility of the product, which could potentially affect device safety and efficacy during use in electrophysiology procedures.
Patients and healthcare providers who have received or used any of the recalled catheters should contact Stryker Sustainability Solutions or their healthcare provider for instructions. The lot numbers and UDI information are available in the full recall documentation to help identify affected units.
The recalled product
- Product
- BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 3,063
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 00885825003845
- Lot Numbers: 3021656
- 4158368
- 4305347
- 4457640
- 4560383
- 4660045
- 4815497
- 4881594
- 4987017
- 5032942
- 3107869
- 4160047
- 4305348
- 4457904
- 4562726
- 4660052
- 4815499
- 4881600
- 4987018
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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Similar recalls
- HighStryker Recalls Reprocessed Diagnostic Electrophysiology Catheters and Cables
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- HighStryker Recalls Reprocessed Electrophysiology Catheter Cables Due to Sterility Breach
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