Express Dry Seal Chest Drains Recalled for Insufficient Setup Instructions
Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (models 4000-100N and 4050-100N) due to inadequate instructions for proper catheter and patient tube connection setup. No injuries have been reported.
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: This is a Class II recall for a medical device with inadequate instructions for proper setup. While no injuries or deaths have been reported, improper setup of a chest drain could result in patient harm, making this a risk-of-harm product without reported injury.
Plain-English summary
Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (models 4000-100N and 4050-100N). The recall affects 48,339 units: 48,148 distributed in the United States and 193 in other countries.
The instructions for use do not provide sufficient guidance for proper setup of catheters and patient tube connections with single collection chamber chest drains.
All units manufactured on or after July 21, 2020 and distributed on or after August 6, 2020 are included in the recall.
Patients and healthcare facilities should contact Atrium Medical Corporation for clarification on proper setup and use of these devices.
The recalled product
- Product
- Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drain
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 (6)
- UDI-DI: (1)4000-100N DRAIN
- EXPRESS
- SINGLE 20650862115134
- (2) 4050-100N DRAIN
- 2020 Distribution Dates: Any product shipped on and after August 6
- 2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
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