| Date Initiated by Firm | August 15, 2024 |
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| Date Posted | September 19, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3178-2024 |
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| Recall Event ID |
95171 |
| 510(K)Number | K080807 |
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| Product Classification |
Set, tubing, blood, with and without anti-regurgitation valve - Product Code FJK
|
| Product | STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2010M2096 |
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| Code Information |
UDI-DI 04046964367786; All Unexpired Lot Numbers
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Recalling Firm/
Manufacturer |
B Braun Medical Inc
824 12th Ave
Bethlehem PA 18018-3524
|
| For Additional Information Contact | Allison Longenhagen
001-484-2408373 |
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Manufacturer 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 |
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FDA Determined
Cause 2 | Device Design |
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| 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 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. |
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| Quantity in Commerce | 9864165 units |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = FJK
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