Recall Z-1480-2012 ยท FMI Needle, Hypodermic, Single Lumen
Churchill Medical Systems, Inc.
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.
| Date | May 1, 2012 (initiated Apr 16, 2012) |
| Status | Terminated |
| Reason | Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set, ; however, the product label states 20Ga MBS-2010 code listed on device label. |
| Root cause | Labeling False and Misleading |
| 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 |
| Quantity | 552 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: IN, KS, KY, NY,MA, MI , and TX; and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K873957 | NON-CORING HUBER TYPE NEEDLES Advantage Medical Systems, Inc., Oct 23, 1987 |