| | Class 2 Recall
Churchill Medical Systems 22Ga Winged Infusion Set |  |
| Date Posted |
May 01, 2012 |
| Recall Number |
Z-1480-2012 |
| Product |
Churchill Medical Systems Winged Infusion Set, 22Ga, 1",
Latex-Free Winged Infusion Set
Product Code: MBS-2210
Huber type needle set used for the infusion of medical fluids into implantable ports. |
| Code Information |
Lot Number: 1202077
|
Recalling Firm/
Manufacturer |
Churchill Medical Systems, Inc.
87 Venture Drive
Dover, New Hampshire 03820-5914 |
| Consumer Instructions |
Contact the recalling firm for information |
Reason for
Recall |
Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set, ; however, the product label states 20Ga MBS-2010 code listed on device
label.
|
| Action |
The firm, VYGON, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 16, 2012 to its customers via overnight, courier service. The letter described the product, problem and actions to be taken. The customers were instructed to check their stock for the products included within the scope of the recall; count and document their affected inventory; contact Vygon's Customer Service Department at 1-800-473-5414 for return merchandise authorization number; return the affected product; complete and immediately return the Acknowledgement and Inventory Return Form via fax to 215-672-6740 and send the original form with their shipment . Distributors were instructed to communicate this recall to their customers and provide them with the Acknowledgement and Inventory Return Form for completion and return.
If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@yygonus.com. |
| Quantity in Commerce |
552 units |
| Distribution |
Worldwide distribution: USA (nationwide) including states of: IN, KS, KY, NY,MA, MI , and TX; and country of: Canada. |
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