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Combined Spinal & Epidural recallZ-2467-2019 · B. Braun Medical, Inc. · initiated Jul 10, 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

The filter capacity is not achieved due to damage of the filter membrane.

FDA root cause category: Under Investigation by firm

What the company is doing

1. Review the Device Recall Notification entirety and ensure that all users in your organization are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the consumer level. 2. Determine your current inventory of the affected lots within your facility. Do not destroy any affected product. 3. Utilizing the attached, 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 [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 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-2467-2019
Status
Terminated
Initiated by the company
Jul 10, 2019
Recalling firm
B. Braun Medical, Inc.
Quantity
200 units
Product code
OFT
Distribution
CA FL MO TX MN AL GA NC IL PA

Product description

ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115

Code information (models, lots, serial numbers)

Lot # 0061620288 UDI: 04046964940637

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 83478).

Sources and updates

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