Z-3049-2011

Churchill Medical Latex-Free IV Start Kit

Name: Z-3049-2011 Churchill Medical Latex-Free IV Start Kit
Creator: Churchill Medical Systems, Inc.
Published: 2011-07-15
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2011-07-15 / Terminated / root cause: manufacturing process

FDA source

Churchill Medical Systems, Inc. began a recall of Churchill Medical Latex-Free IV Start Kit Product Code: AMS-623ATLF The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape... on 2011-07-15. The reason FDA records is "Outer Kit labeled expiration date longer than the expiration of the shortest expired product". 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-3049-2011
Status: Terminated
Initiated: 2011-07-15
Posted: 2011-08-22
Terminated: 2013-03-27
Recalling firm: Vygon Mfg
Product: Churchill Medical Latex-Free IV Start Kit Product Code: AMS-623ATLF The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape roll, 2 gauze sponges, a 3M" Tegaderm" dressing, and a dressing change label AMS-623ATLF is a convenient kit that aids in preparing the insertion site for the start of intravenous therapy
Product code: LRS I.V. Start Kit
Reason for recall: Outer Kit labeled expiration date longer than the expiration of the shortest expired product
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Churchhill Medical Systems, Inc A Vygon Company issued an URGENT MEDICAL DEVICE RECALL letter was via overnight courier mail on July 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The product was requested to be returned. Distributors were provided with instructions to communicate the recall to customers who received the affected product by providing a copy of the notification and a copy of the Recall Acknowledgement and Inventory Return Form. The form should be completed in its entirety, signed and returned to the Distributor. Contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email to customerservice @vygonus.com
Quantity in commerce: 130,750 units
Distribution: Nationwide Distribution
Product codes and lots: Lot Numbers: 609134, 610166, 611100, 612074, 701180, 703021, 704088 706150, 707106, 708503, 709052, 710051, 711074, 711176 801504, 802064, 803116, 805120, 810040, 810150, 812020 902044, 903117, 906039, 907156, 908040, 910558, 912038 1007141

Product code LRS

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