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Recall Observatory FDA recall evidence

Device product

Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07

Z-1120-2019

March 05, 2019

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 82350
Status
Terminated
Classification
Class II
Quantity
21220 total cases of 20
Official record key
device-enforcement:Z-1120-2019

Official wording

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

Code information: 18105594 18105595 18105596 18105597

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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