Z-2391-2011

Churchill Medical Systems AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. Churchill Medical Systems...

Name: Z-2391-2011 Churchill Medical Systems AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. Churchill Medical Systems...
Creator: Vygon Corporation
Published: 2011-04-19
License: https://open.fda.gov/license/

Vygon U.S.A. / initiated 2011-04-19 / Terminated / root cause: manufacturing process

FDA source

Vygon Corporation began a recall of Churchill Medical Systems AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. Churchill Medical Systems AMS-9189CP (Dressing Change Kit)-Large Glove. The devices... on 2011-04-19. The reason FDA records is "Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2391-2011
Status: Terminated
Initiated: 2011-04-19
Posted: 2011-06-11
Terminated: 2012-06-18
Recalling firm: Vygon U.S.A.
Product: Churchill Medical Systems AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. Churchill Medical Systems AMS-9189CP (Dressing Change Kit)-Large Glove. The devices intended use is a Dressing Change Kit.
Product code: LKB Pad, Alcohol, Device Disinfectant
Reason for recall: Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall. 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: AM-9189CP-1 =4,800 units and AM-9189CP= 2,000
Distribution: United States (FL, MA, MD, and VA).
Product codes and lots: AMS-9189CP-1, Lot Numbers: 1006150, 1006149 and 1008143. AMS-9189CP, Lot Number: 1003527.

Product code LKB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)