Recall StatusTerminated
Date Initiated2018-07-19
Date Terminated2019-05-23
Product Quantity800 units
Reason for Recall
A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patient.
Firm Action
Urgent Medical Device Recall notification letters dated 7/19/18 were distributed to customers. The letters instructed customers to perform the following actions:
1. Identify the product.
2. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
3. Consider all potential users of this product in your wholesale and/or user level supply chain. Your assistance is appreciated and necessary to prevent patient harm.
4. Follow the attached Destruction Instructions to disable the wire tip to safely destroy this product to prevent activation or future use of this product.
5. Complete and return the enclosed response form as soon as possible. Please provide objective evidence of the product destruction and we will credit your account.
Customers were also contacted via phone beginning 8/1/18
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: CA, DC, FL, IA, ID, IL, MA, MI, MN, NY, OK, PA, TN, TX, UT, and WA and the countries of Australia, France, Netherlands, Spain, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.