STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Ca

FDA device recall Z-3177-2024 · posted 2024-09-19 · Open, Classified

Recall details

Recalling firm

B Braun Medical Inc

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

Action taken

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 recalls@bbraunusa.com 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.

Root cause

Device Design

Status

Open, Classified

Product code

FJK

Quantity affected

142336 units

Distribution

US Nationwide distribution.

Date initiated

2024-08-15

Date posted

2024-09-19

Location

Bethlehem, PA

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