FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
- Recall number
- Z-1121-2019
- Recalling firm
- Becton Dickinson & Company
- Product
- Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
- Status
- Terminated
- Initiated
- 2019-03-05
- Posted
- not on file
- Terminated
- 2020-07-15
- Reason
- The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.
- Root cause
- 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
- 21220 total cases of 20
- Distribution
- Distributed to accounts in AL, CA, DC, FL, LA, MD, NE, TN, VA, and WA.
- Lot, serial or model codes
- 18105828 18105830 18105857 18105858
- 510(k) numbers
- ["K931173"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28