| | Class 2 Device Recall BD Pyxis Anesthesia Station 4000 |  |
| Date Initiated by Firm | April 30, 2026 |
| Date Posted | June 03, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2300-2026 |
| Recall Event ID |
98895 |
| Product Classification |
Cabinet, table and tray, anesthesia - Product Code BRY
|
| Product | BD Pyxis Anesthesia Station 4000
REF: 338
Medication cabinet |
| Code Information |
All Serial Numbers/UDI:10885403477829 |
| FEI Number |
2016493
|
Recalling Firm/ Manufacturer |
CareFusion 303, Inc. 10020 Pacific Mesa Blvd San Diego CA 92121-4386
|
| For Additional Information Contact | Recall Customer Response Forms 1800-727-6102 |
Manufacturer Reason for Recall | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. |
FDA Determined Cause 2 | Component design/selection |
| Action | On April 30, 2026, CareFusion (subsidiary of Becton, Dickinson and Company) issued a Urgent Medical Device Recall Notification, via mail or Email. CareFusion ask consignees to take the following actions:
1. Dispensing cabinets can continue to be used as intended.
2. If you suspect that the Bio-ID Scanner is hot, please discontinue the use of Scanner and file a complaint.
3. Review and update facility policies and procedures related to situations where the Bio-ID Scanner is unavailable to mitigate delays in care.
4. Complete the attached Customer Response Form and return to the BD contact noted on the form.
|
| Quantity in Commerce | 1 unit |
| Distribution | US: Nationwide
OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ, PT, QA, SA, SG, TH, TW |
| Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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