BARD Dynamic Tip Steerable Reprocessed Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200131) due to incomplete seals on sterile product packaging. The recall affects 61 units distributed nationwide in the US and in Israel and Canada.
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 compromised sterile barrier (incomplete seals). Although no illness or injury has been reported, incomplete seals on sterile products represent a risk-of-harm scenario where the device's intended protective function is compromised, meeting the High severity criterion.
Plain-English summary
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters, Product Number 200131, due to incomplete seals on the sterile product packaging. This defect could compromise the sterile barrier of the device.
The recall involves 61 units with UDI 00885825002930 across multiple lot numbers, distributed throughout the United States and in Israel and Canada. The affected lot numbers include 3966097, 4314254, 4490535, 4511367, 4517632, 4607771, 4762688, 4056491, 4401626, 4490540, 4511368, 4567842, 4628229, 4775309, 4137164, 4455383, 4490542, 4511369, 4567844, 4628232, 4875058, 4154024, 4463033, 4490544, 4511370, 4567866, 4628234, 5023284, 4165178, 4472622, 4495807, 4511372, 4567888, 4628242, 5023285, 4250497, 4490533, 4502016, 4511375, 4567898, 4665767, 5069705, 4300586, 4490534, 4511155, 4514004, 4607745, and 4762686.
Healthcare providers and facilities that may have received these catheters should check their inventory against the affected lot numbers and contact Stryker Sustainability Solutions with any questions about this recall.
The recalled product
- Product
- BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 61
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 00885825002930
- Lot Numbers: 3966097
- 4314254
- 4490535
- 4511367
- 4517632
- 4607771
- 4762688
- 4056491
- 4401626
- 4490540
- 4511368
- 4567842
- 4628229
- 4775309
- 4137164
- 4455383
- 4490542
- 4511369
- 4567844
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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