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Cysto, FTCY03L recallZ-3243-2024 · American Contract Systems, Inc. · initiated Aug 7, 2024

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

ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

FDA root cause category: Under Investigation by firm

What the company is doing

Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " -Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Discard all affected kits and document on the enclosed Response Form."

Recall details

Recall number
Z-3243-2024
Status
Open, Classified
Initiated by the company
Aug 7, 2024
Posted by the FDA
Sep 24, 2024
Recalling firm
American Contract Systems, Inc.
Quantity
36 units
Product code
NWU
Distribution
US Nationwide distribution in the states of MO, MN, MA, OH, NE.

Product description

Cysto, FTCY03L; Medical convenience kit

Code information (models, lots, serial numbers)

UDI-DI: 00191072189295; Lot: 2405033; Exp: 05/03/2025

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 95261).

Sources and updates

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