StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number: JUZKF615 & JUAPF369.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. 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.
Product Codes/Lot Numbers:
Lot Number: JUZKF615 & JUAPF369.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0982-2017
Related Recalls
Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.
BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
Bard Access Systems
Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.