Recalls / —

—#178794

Product

Safeline Y-Type Blood Set, Catalog Number NF5140

FDA product code

FPA — Set, Administration, Intravascular

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K840212, K931377

Affected lot / code info

GUIDID: 04046964187483 Lot Numbers: 61681745 - Expiration Date: May 31, 2024, 61685109 - Expiration Date: June 30, 2024

Why it was recalled

Potential for leakage at the joint between the blood filters and tubing

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

B. Braun Medical, Inc.

Address

901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern

US Nationwide

Timeline

Recall initiated

2019-11-20

Terminated

2020-10-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #178794. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.