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Terminated

Churchill Medical Latex-Free IV Start Kit Product Code: AMS-623ATLF The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape roll, 2 gauze sponges, a 3M" Tegaderm" dressing, and a dressing change label AMS-623ATLF is a convenient kit that aids in preparing the insertion site for the start of intravenous therapy

FDA Recall Z-3049-2011 · Posted 2011-08-22

Recall StatusTerminated
Product CodeLRS
Date Initiated2011-07-15
Date Terminated2013-03-27
Product Quantity130,750 units

Reason for Recall

Outer Kit labeled expiration date longer than the expiration of the shortest expired product

Firm Action

Churchhill Medical Systems, Inc A Vygon Company issued an URGENT MEDICAL DEVICE RECALL letter was via overnight courier mail on July 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The product was requested to be returned. Distributors were provided with instructions to communicate the recall to customers who received the affected product by providing a copy of the notification and a copy of the Recall Acknowledgement and Inventory Return Form. The form should be completed in its entirety, signed and returned to the Distributor. Contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email to customerservice @vygonus.com

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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