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Terminated

TFE Coated Curved Newton LLT

FDA Recall Z-0963-2018 · Posted None

Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeDQX
Date Initiated2017-10-13
Date Terminated2019-10-23
Product Quantity3,364

Reason for Recall

Label does not state that the product is heparin-coated.

Firm Action

On October 31, 2017 an URGENT MEDICAL DEVICE CORRECTION was issued to customers requesting the following, including a corrective action: Step 1: Determine if your product is included in the affected lot ranges by comparing your lot number to the listing provided. " If your product is not affected, complete the Acknowledgement and Receipt Form. " If your product is affected, proceed to Step 2. Step 2: Remove a Heparin Coated label from the label sheet provided and apply to the top right corner of your affected unit. o If you need additional labels, please contact Stericycle at 855.215.4967. If you would like assistance, representatives are available to support you. To request assistance, please contact Stericycle at 855.215.4967

Root Cause

Labeling Change Control

Distribution Pattern

Nationally

Official Source

View FDA Recall →

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

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