Z-2469-2019Class II

CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183

Name: Z-2469-2019 CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
Creator: B. Braun Medical, Inc.
Published: 2019-07-10
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2019-07-10 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183 on 2019-07-10. FDA classified it as Class II and gives the reason as "The filter capacity is not achieved due to damage of the filter membrane". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2469-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-10
Posted: 2019-09-05
Terminated: 2020-08-21
Recalling firm: B Braun Medical Inc
Product: CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
Product code: OFT Spinal Epidural Anesthesia Kit
Reason for recall: The filter capacity is not achieved due to damage of the filter membrane.
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 540 units
Distribution: CA FL MO TX MN AL GA NC IL PA
Product codes and lots: Lot # 0061536635 Exp: 10/31/2018 Lot # 0061620271 Exp:11/30/2019 UDI: 04046964941337

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2469-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2466-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2467-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2468-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2469-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2470-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2471-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2472-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2473-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2474-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05

Product code OFT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)