Agency classClass IIOur severity:High FDA (Devices)·Z-1081-2017·Announced 2017-02-01

Atrium Medical Recalls Pediatric Ocean Drains Due to Non-Sterile Packaging

Atrium Medical is recalling Pediatric Chamber Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device where the outer packaging is not sterile, which poses a risk of infection or harm to patients, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Atrium Medical Corporation is recalling its Pediatric Chamber Ocean Drains, specifically the Ocean Infant/Pediatric drain with in-line connector and suction control stopcock. The recall is being conducted because the outer packaging of these devices is not sterile. The product is used to evacuate air and/or fluid from the chest cavity or mediastinum to help re-establish lung expansion and restore breathing dynamics.

The recall includes 964,463 cases in the United States and 521,975 cases outside the United States. The affected units are identified by all lot numbers with an expiration date prior to October 2019. The devices were distributed worldwide, including in the United States and numerous international markets such as Australia, Canada, China, France, Germany, and the United Kingdom.

Healthcare facilities and consumers should stop using the affected devices immediately. Atrium Medical is the recalling firm responsible for this action. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control stopcock, ¿ in. Tubing, Sims and Pedi connector in bag on back of drain Product Usage: To evacuate air and/or fluid from the chest…
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Surgical / Drainage
Hazard: non-sterile-packaging
infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All Lot Numbers With Expiration Date Prior To October 2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Same manufacturer · Atrium Medical Corporation

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