Device recall: Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.

Cardinal Health 200, LLC, Waukegan, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

Device events that started in 2022

839

Share of these events in Class II

88%

Product records in this event

28Median of the firm: 3

Events of the firm on the register

59

Cardinal Health 200, LLC: all 59 events

• FDA enforcement report Z-0967-2023The FDA record of the first product of this event.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Where was the product distributed?

The FDA record gives this distribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.

What quantity of product is in FDA event 91322?

The event has 28 product records. The first record gives this quantity: 1150 units

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many device recalls of 2022 have the same class?

88% of the 839 device events that started in 2022 are in Class II.