BD Pyxis MedStation ES AUX, REF 324

FDA device recall Z-0972-2025 · posted 2025-01-17 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,

Action taken

BD issued an Urgent Medical Device Product Advisory to its consignees on 02/14/2023 via letter. The notice explained the problems with the device, health hazards, and requested the following actions be taken: "1. Customers may continue to use these devices as intended and should file a complaint via the Customer Portal at https://www.bd.com/self-service or call BD Support at 1-800-727-6102, should you experience drawer or door failures. 2. If you experience delays in access to medication due to a drawer or door failure, ensure backup procedures (which may include but may not necessarily be limited to keys, emergency medication supplies, alternate devices in proximity, etc.) are in place and staff have all been properly trained on them. 3. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and that you understand the information provided in this letter. 4. If you have specific questions about this letter, please contact 1-866-583-8783." The firm issued a second notice on 01/09/2024 with the same information.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

BRY

Quantity affected

39615 units

Distribution

Worldwide

Date initiated

2023-02-14

Date posted

2025-01-17

Location

San Diego, CA