—#171456

Product

Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K931173
Affected lot / code info: 18105828 18105830 18105857 18105858

Why it was recalled

The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Distributed to accounts in AL, CA, DC, FL, LA, MD, NE, TN, VA, and WA.

Timeline

Recall initiated: 2019-03-05
Terminated: 2020-07-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171456. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.