FDA Medical Device Recalls (openFDA)
CAREFUSION: BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
- Recall number
- Z-1759-2022
- Recalling firm
- CAREFUSION
- Product
- BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
- Status
- Open, Classified
- Initiated
- 2022-08-01
- Posted
- 2022-09-13
- Terminated
- not on file
- Reason
- Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
- Root cause
- Error in labeling
- Action
- On 8/1/22 Correction-recall notices were emailed or mailed to customers and distributors who were asked to do the following: 1) Destroy affected devices following your institutions process for destruction. 2) Share this notification with all users within your facility network to ensure all are aware. The correction-recall notice should also be shared with any organization where the potentially affected product has been transferred. 3) Complete and return the response form. In addition distributors were informed that the recalling firm plans to notify all affected customers directly so they were asked to provide a a list of customers who received affected devices. The distributor response form has a check box if the distributor declines to provide a customer list to the recalling firm because they have notified customers about the correction-recall. A copy of the customer communication was provided to the distributor. If customers or distributors require additional assistance they are aske to call 1-844-823-5433, Mon-Fri 8:00 AM - 5:00 PM CT or productcomplaints@bd.com
- Quantity
- 100
- Distribution
- US: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC, IN, KY, MO, MD, PA, CA, IL, SD, GA, MS, AZ, WV, ID, WY, VT, NM, OR, NJ, OK, KS, MN
- Lot, serial or model codes
- UDI-DI: 10885403237669, Lots: 22029674
- 510(k) numbers
- ["K051499"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3012410077
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28