Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
This recall has been terminated (originally issued March 5, 2019).
- Company
- Becton Dickinson & Company
- Recall Initiated
- March 5, 2019
- Terminated
- July 15, 2020
- Recall Number
- Z-1121-2019
- Quantity
- 21220 total cases of 20
- Firm Location
- Franklin Lakes, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed to accounts in AL, CA, DC, FL, LA, MD, NE, TN, VA, and WA.
Lot / Code Info
18105828 18105830 18105857 18105858
Root Cause
Under Investigation by firm
Action Taken
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