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Blood Administration Set recallZ-0940-2020 · B. Braun Medical, Inc. · initiated Nov 20, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from B. Braun Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0940-2020
Status
Terminated
Initiated by the company
Nov 20, 2019
Recalling firm
B. Braun Medical, Inc.
Quantity
3,300 units
Product code
FPA
FDA submissions
K840212, K931377
Distribution
US Nationwide

Product description

Safeline Y-Type Blood Set, Catalog Number NF5140

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 84365).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page