Z-3001-2026Class II

American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN

Name: Z-3001-2026 American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
Creator: American Contract Systems Inc
Published: 2026-06-29
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2026-06-29 / Open, Classified / root cause: manufacturing process

FDA source

American Contract Systems Inc began a recall of American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN on 2026-06-29. FDA classified it as Class II and gives the reason as "The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3001-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-29
Posted: 2026-08-21
Recalling firm: American Contract Systems, Inc.
Product: American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter dated 6/29/26 was sent to customers. ACTIONS TO TAKE: "Identify, segregate, and quarantine all impacted product. Other components within the convenience kits can still be used once kit is properly labeled with the warning label below. "Add warning labels to affected ACS kits to ensure all users are aware of the actions below and identified in the enclosed Medline recall notice. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. "Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have, or to request printed labels. "Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. "Complete the attached Recall Response Form and return by July 17, 2026. Report any quality problems or adverse events associated with the products listed in this notification to [email protected] . Your assistance is appreciated and necessary to prevent any risk to patient or medical professional health as a result of not following these instructions.
Quantity in commerce: 30 units
Distribution: US Nationwide distribution in the states of IA, OH.
Product codes and lots: Lot Code: Lot Number: 42-8768511 UDI: 191072239907 Expiration Date: 1/6/2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3001-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3000-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-3001-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-3002-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-3003-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21

Product code OEZ

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 2026-09-12. View this recall on fda.gov (opens on fda.gov)