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Terminated

AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.

FDA Recall Z-1484-2017 · Posted None

Recall StatusTerminated
Product CodeFPA
Date Initiated2017-02-20
Date Terminated2019-04-22
Product Quantity30,700

Reason for Recall

Incorrect priming volume printed on the device package.

Firm Action

Recall letters were sent to the customer via email and fax on 2/20/2017. They were asked to take the following actions: The recall will be conducted at no cost to you. To effect return of the recalled product and replacement with new inventory, we request your cooperation in the following steps: 1. Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2. Count and document your affected inventory on the "Recall Acknowledgement and Inventory Return Form; 3. Fax or email the form to Vygon including customer contact information; 4. Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5. Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up; 6. All inventory will be credited or replaced at no cost to you. If you have questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-4 73-5414, or by e-mail at [email protected].

Root Cause

Error in labeling

Distribution Pattern

US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV

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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