Recall Z-1121-2019— Becton Dickinson & Company

Name: FDA recall Z-1121-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-05

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-03-05, terminated 2020-07-15. It names one FDA 510(k) clearance: K931173. Product: Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07. Reason: The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2019-03-05
Terminated: 2020-07-15
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K931173 — PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CHImed Corp.·cleared 1994-04-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.