Z-1121-2019 Class II Terminated

Recalled by Becton Dickinson & Company — Franklin Lakes, NJ

FDA device recall Z-1121-2019 was initiated by Becton Dickinson & Company on March 5, 2019 and is designated Class II. 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. The recall status is terminated (terminated July 15, 2020). Affected quantity: 21220 total cases of 20.

Recall Details

Product Type
Devices
Report Date
April 17, 2019
Initiation Date
March 5, 2019
Termination Date
July 15, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21220 total cases of 20

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.

Distribution Pattern

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

Code Information

18105828 18105830 18105857 18105858