CareFusion 303, Inc. recalls BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications…
Reason for recall
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare providerUDIUDI 10885403512629/12 affected lots1615336016161369161613701616137116187328161873291618733015495060
+4 more
15930189161613681617344416283947
What the firm is doing
On February 14, 2023 and January 9. 2024 Carefusion issued a Urgent medical Device Product Advisory" Recall Notification to affected consignees. Carefusion asked consignees take the following actions: 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. 5. Any adverse health consequences experienced with the use of this product should be reported to BD and may be reported to the FDA s MedWatch Adverse Event Reporting Actions to be taken by distributor 1. Please provide a copy of this notification to any customers who may have received products listed in the Affected Products table above. 2. 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.
DistributionShow detailsHide
US: Nationwide OUS:JP IT IN DE GB KR NL TW ES BE AU BH CA BR NZ FR AR QA MX CL TR SA MY CH IL IE TH SG KW MA FI AE EG BS BM GR MC PL LB MO IQ TN NO PH CN HK CO JO OM
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1125-2025
- FDA device classification · BRYOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.6100The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find CareFusion 303, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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