AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.

FDA device recall Z-0813-2014 · posted 2014-01-23 · Terminated

Recall details

Recalling firm

Churchill Medical Systems, Inc.

Reason for recall

Defective component may cause extension sets to leak.

Action taken

Vygon sent an Urgent Medical Device Recall letter dated January 7, 2014 to each customer via courier service and email. The letter identified the affected product, problem and actions to be taken. The recall letter instructs customers to: 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 the customer. Distributors were provided with instructions on how to handle product that was further distributed by them. For questions contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email at customerservice@vygonus.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FPA

Quantity affected

3850

Distribution

US Nationwide Distribution in the states of: NY, VA, IL, MO, OR, FL, DE, OH

Date initiated

2014-01-07

Date posted

2014-01-23

Date terminated

2014-11-03

Location

Dover, NH

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