Stryker Recalls Reprocessed Ablation Catheter Cables Due to Sterility Concerns
Stryker is recalling reprocessed ablation catheter cables because a breach in sterile packaging may have resulted in non-sterile product.
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: The recall involves a medical device where a breach in sterile packaging may have resulted in non-sterile product. This represents a risk of harm (infection) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Sustainability Solutions is recalling reprocessed ablation catheter cables, catalog numbers CR3425CT and CR3434CT. The recall is due to a potential breach in the sterile packaging, which may have resulted in the product being non-sterile.
The affected products were distributed in the United States to the following states and districts: MI, TX, TN, IN, AL, FL, PA, AK, WI, MT, SC, CO, CA, NH, NC, NJ, DE, AZ, MN, MS, GA, DC, IA, NY, NM, KS, OH, OK, SD, OR, NV, VA, MD, and WA. Foreign distribution was reported to CA. The recall covers all lots with expiration dates between March 1, 2018, and October 31, 2018.
Healthcare providers and facilities should stop using the affected cables and contact Stryker Sustainability Solutions for further instructions on the recall.
The recalled product
- Product
- Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a multi-pin connector on the proximal end which connects…
- Manufacturer
- Stryker Sustainability Solutions
Distribution
Part of a larger recall action
This product is one of 2 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.
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