Z-0937-2020Class II

Y-Type Blood Set, Catalog Number 490314

Name: Z-0937-2020 Y-Type Blood Set, Catalog Number 490314
Creator: B. Braun Medical, Inc.
Published: 2019-11-20
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2019-11-20 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Y-Type Blood Set, Catalog Number 490314 on 2019-11-20. FDA classified it as Class II and gives the reason as "Potential for leakage at the joint between the blood filters and tubing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0937-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-20
Posted: 2020-02-02
Terminated: 2020-10-16
Recalling firm: B Braun Medical Inc
Product: Y-Type Blood Set, Catalog Number 490314
Product code: FPA Set, Administration, Intravascular
Reason for recall: Potential for leakage at the joint between the blood filters and tubing
Root cause tag: manufacturing process
FDA 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 in commerce: 5,616 units
Distribution: US Nationwide
Product codes and lots: GUIDID: 04046964527180 Lot Numbers: 61674868 - Expiration Date April 30, 2022, 61677175 - Expiration Date April 30, 2022, 61678259 - Expiration Date May 31, 2022, 61685087 - Expiration Date June 30, 2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0937-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0935-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-01
Z-0936-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-01
Z-0937-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-01
Z-0938-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-01
Z-0939-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-01
Z-0940-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-01
Z-0941-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-01

Product code FPA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)