Z-1480-2012

Churchill Medical Systems Winged Infusion Set, 22Ga, 1", Latex-Free Winged Infusion Set

Name: Z-1480-2012 Churchill Medical Systems Winged Infusion Set, 22Ga, 1", Latex-Free Winged Infusion Set
Creator: Churchill Medical Systems, Inc.
Published: 2012-04-16
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2012-04-16 / Terminated / root cause: labeling and UDI

FDA source

Churchill Medical Systems, Inc. began a recall of 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... on 2012-04-16. The reason FDA records is "Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set, ; however, the product label states 20Ga MBS-2010 code listed on device label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1480-2012
Status: Terminated
Initiated: 2012-04-16
Posted: 2012-05-01
Terminated: 2013-03-28
Recalling firm: Vygon Mfg
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.
Product code: FMI Needle, Hypodermic, Single Lumen
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.
Root cause tag: labeling and UDI
FDA 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 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 [email protected].
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.
Product codes and lots: Lot Number: 1202077

Product code FMI

K873957Class IINon-Coring Huber Type NeedlesAdvantage Medical Systems, Inc. / cleared 1987-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)