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Terminated

AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.

FDA Recall Z-0787-2017 · Posted None

Recall StatusTerminated
Product CodeFPA
Date Initiated2016-11-18
Date Terminated2017-10-23
Product Quantity31,500

Reason for Recall

Incorrect priming volume is printed on the device package.

Firm Action

Vygon sent an Urgent Medical Device Recall letter dated November 18, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to take the following actions: 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. For questions contact local sales representative or Vygon's Customer Service Department at 1-800-473-5414.or by email at [email protected].

Root Cause

Device Design

Distribution Pattern

US distribution in the state of CA

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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