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Terminated

Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396

FDA Recall Z-1119-2019 · Posted None

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDQY
Date Initiated2019-01-10
Date Terminated2020-06-04
Product Quantity45 eaches total (US)

Reason for Recall

The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

Firm Action

Teleflex issued Urgent Medical Device Notification to US consignee notification letter on 10th January 2019 via FedEx 2-day mail. Actions to be taken to remove product from the facilities: A: The affected customer is instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form

Root Cause

Error in labeling

Distribution Pattern

FL, NC

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K862056[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIPArrow Intl., Inc. · 1986-08-25

Official Source

View FDA Recall →

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

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