StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and fo
FDA device recall Z-0982-2017 · posted 2017-01-10 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
- Action taken
- Bard sent an Urgent Customer Notification letter dated December 12, 2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory and identify any product subject to the notification. Please direct any return requests and/or questions to Shelly Gilbert at 1-800-290-1689.
- Root cause
- Process design
- Status
- Terminated
- Product code
- KMK
- Quantity affected
- 14,500 units total
- Distribution
- Worldwide Distribution - US Nationwide
- Date initiated
- 2016-12-09
- Date posted
- 2017-01-10
- Date terminated
- 2017-05-26
- Location
- Salt Lake City, UT
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