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Terminated

Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products

FDA Recall Z-0723-2019 · Posted None

Recall StatusTerminated
Product CodeDQY
Date Initiated2018-11-14
Date Terminated2020-06-04
Product Quantity15 in the US

Reason for Recall

The lidstock states the incorrect priming volume and flow rates.

Firm Action

The firm, Teleflex, sent an "Urgent Medical Device Notification" letter dated 11/13/2018 to its customers on 11/14/2018. The letter described the product, problem and action to be taken. The customers were instructed to do the following: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgement form, communicate this notification to any of your customer who have received product included within the scope of this notification. 3. Have each of your customers who received the affected product return a completed acknowledgement form to you. 4. Once you have finished collecting and consolidating all of the acknowledgement forms from your customers and placing a copy of this notification with each unit of affected product in your inventory, please completed the enclosed Distributor Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to [email protected]. This will allow us to document completion of this field action. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.

Root Cause

Error in labeling

Distribution Pattern

Worldwide distribution: US (nationwide) distribution to state of: FL and to countries of: Argentina, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, and Peru.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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