Bard Access Systems: 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.).

Agency Publication Date: January 10, 2017

Affected Products

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 i

Lot Number: JUZGF345 & JUAQF020

Lot Numbers:

Number

Product: 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 inserte

Lot Number: JUZKF615 & JUAPF369.

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75908

Status: Resolved

Manufacturer: Bard Access Systems

Manufactured In: United States

Units Affected: 2 products (30,000 units total; 14,500 units total)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Number: JUZGF345 & JUAQF020

Lot Numbers:

Number

Lot Number: JUZKF615 & JUAPF369.

Lot Numbers:

Number