Recall Z-0981-2017
Bard Access Systems · initiated December 9, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
StatLock PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock PICC Plus and StatLock CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively.
Codes / lots: Lot Number: JUZGF345 & JUAQF020
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.).
FDA-determined cause: Process design
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.
Details
- Recall number
- Z-0981-2017
- Initiated
- December 9, 2016
- Posted by FDA
- January 10, 2017
- Terminated
- May 26, 2017
- Product code
- KMK – Device, Intravascular Catheter Securement
- Quantity
- 30,000 units total
- Distribution
- Worldwide Distribution - US Nationwide
- Recalling firm
- Bard Access Systems, Salt Lake City, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0982-2017 Class II | StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit…Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices… | 12/09/2016Terminated |