FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Y-Type Blood Set, Catalog Number 490530
- Recall number
- Z-0939-2020
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Y-Type Blood Set, Catalog Number 490530
- Status
- Terminated
- Initiated
- 2019-11-20
- Posted
- not on file
- Terminated
- 2020-10-16
- Reason
- Potential for leakage at the joint between the blood filters and tubing
- Root cause
- Nonconforming Material/Component
- Action
- On 11/20/2019, B Braun Medical Inc. issued Urgent Medical Device letters and Product Removal Acknowledgment forms to customers. On 11/20/2019, B Braun Medical Inc. also issued a press release. Actions Required By BBMI Customer/User: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward a copy of the recall notification to your customers. 2. Determine your current inventory of the affected lots within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the Product Removal Acknowledgement, form, record the total number of individual units (within partial cases) and the number of full-unopened cases. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Removal Acknowledgement form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance. 5. If you have any full cases, partial cases or unused individual pieces of these affected products as identified in the Product Removal Acknowledgement form that was submitted to BBMI Quality Assurance Department, a BBMI Customer Support Representative will contact you to provide instructions for handling the affected product and arrange for return to BBMI. This may include credit or replacement product. Should you identify product where this issue has occurred, please report the event promptly to BBMI by contacting our Clinical and Technical Support Department at 1-800-854-6851.
- Quantity
- 9,000 units
- Distribution
- US Nationwide
- Lot, serial or model codes
- GUIDID: 04046955203321 Lot Numbers: 61674878 - Expiration Date: April 30, 2022, 61677192 - Expiration Date: April 30, 2022, 61678186 - Expiration Date: April 30, 2022, 61681736 - Expiration Date: May 31, 2022, 61685105 - Expiration Date: June 30, 2022
- 510(k) numbers
- ["K060231","K140311","K922637"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- 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