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American Contract System Convenience Kit, D & C PACK… recallZ-3003-2026 · American Contract Systems Inc · initiated Jun 29, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from American Contract Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-3003-2026
Status
Open, Classified
Initiated by the company
Jun 29, 2026
Posted by the FDA
Aug 21, 2026
Recalling firm
American Contract Systems Inc
Quantity
12 units
Product code
OEZ
Distribution
US Nationwide distribution in the states of IA, OH.

Product description

American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H

Code information (models, lots, serial numbers)

Lot Code: Lot Number: 70-054952 UDI: 191072219947

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 99514).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page