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Terminated

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.

FDA Recall Z-0981-2017 · Posted 2017-01-10

Recalling FirmBard Access Systems
Recall StatusTerminated
Product CodeKMK
Date Initiated2016-12-09
Date Terminated2017-05-26
Product Quantity30,000 units total

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.).

Firm Action

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

Distribution Pattern

Worldwide Distribution - US Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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