Date Initiated by Firm | March 05, 2019 |
Create Date | April 10, 2019 |
Recall Status1 |
Terminated 3 on July 15, 2020 |
Recall Number | Z-1120-2019 |
Recall Event ID |
82350 |
510(K)Number | K931173 |
Product Classification |
Set, administration, intravascular - Product Code FPA
|
Product | Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07 |
Code Information |
18105594 18105595 18105596 18105597 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
|
For Additional Information Contact | Customer Advocacy 888-812-3266 |
Manufacturer Reason for Recall | The firm has initiated a recall due to a confirmed complaint trend for
kinked tubing on the specified lots of the product. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | On March 5, 2019, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that product was being recalled due to reports of kinked tubing which can lead to occlusion of the sets and reduction in the rate of infusion.
Please Take the Following Actions:
1. Immediately review your inventory for the specific Catalogues (Ref) and lot numbers listed above. Destroy
all product subject to the recall following your institutions process for destruction.
2. Share this recall notification with all users of the product within your facility to ensure that they are also
aware of this recall.
3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether
or not you have any of the impacted material, so that BD may acknowledge your receipt of this
notification and provide product replacement.
If you require further assistance, please contact:
Customer Advocacy
Phone: 888-812-3266
Phone hours: 24 hours a day, 7 days a week
Email: customerfeedback@bd.com |
Quantity in Commerce | 21220 total cases of 20 |
Distribution | Distributed to accounts in AL, CA, DC, FL, LA, MD, NE, TN, VA, and WA. |
Total Product Life Cycle | TPLC Device Report |
|
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FPA
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