Z-3179-2024Class II

STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a...

Name: Z-3179-2024 STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a...
Creator: B Braun Medical Inc
Published: 2024-08-15
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2024-08-15 / Open, Classified / root cause: design

FDA source

B Braun Medical Inc began a recall of STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number... on 2024-08-15. FDA classified it as Class II and gives the reason as "Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-3179-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-15
Posted: 2024-09-19
Recalling firm: B Braun Medical Inc
Product: STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A
Product code: FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Reason for recall: Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Root cause tag: design
FDA root cause: Device Design
Action: B. Braun issued Urgent Medical Device Correction letter on 8/15/24 via USPS. Letter states reason for recall, health risk and action to take: Interim Measures for User: It is recommended that users follow the additional instructions provided in Attachment 01 for connecting the patient connector to the Locksite during prograde rinseback procedures. This attachment should be posted in clinical areas where Streamline Airless System Hemodialysis Bloodlines are utilized and where they are stored until further notice. Actions Required by B. Braun Medical Inc. (BBMI) Customer/User: 1. Review this notice in its entirety. Ensure that all users in your organization of the above-mentioned products, and other concerned personnel are informed about this voluntary correction. Post this notification where the affected products are stored. Note: Product is not being returned as part of this correction notification. a. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The correction is to be extended to the consumer level. b. If you are a distributor that distributes partial cases, please ensure a copy of this notice is forwarded to your consignees. 2. Determine your current inventory. Review your inventory frequently to check these product codes and lot numbers. Post this notification where the affected products are stored. 3. Return the completed "Urgent Medical Device Correction 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). Adverse reactions or quality problems experienced with this product, or questions about this correction may be reported to BBMl's Postmarket Surveillance Department by calling 1-833-425-1464.
Quantity in commerce: 11262112 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI 04046955674992; All Unexpired Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3179-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3173-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3174-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3175-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3176-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3177-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3178-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3179-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19

Product code FJK

K080807Class IIBlood Tubing Sets (Sterile Fluid Path)Nxstage Medical, Inc. / cleared 2008-07-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)