Express Mini 500 Chest Drain Recalled for Inadequate Instructions
The Express Mini 500 Dry Seal Chest Drain has been recalled because its instructions do not adequately warn against draining it for continued use or using it outside healthcare settings. Approximately 8,184 cases were distributed worldwide.
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 an FDA Class II recall of a critical medical device where the Instructions for Use inadequately warn against improper use. While no adverse events have been reported, the risk-of-harm nature of a chest drainage device combined with gaps in precautionary guidance justifies a High severity rating under the rubric criterion for risk-of-harm products.
Plain-English summary
The Express Mini 500 Dry Seal Chest Drain, Part Number 16400, has been recalled by manufacturer Atrium Medical Corporation. The recall involves 8,184 cases (6 units per case) distributed worldwide, including the United States and 34 additional countries.
The recall is due to inadequate Instructions for Use. The IFU does not provide sufficient precautions against draining the device for continued use or sufficient warnings against using the device outside healthcare settings. These gaps in guidance create risk for improper handling of a critical medical device.
Affected lot numbers were manufactured within three years prior to correction initiation. Healthcare providers and facilities should identify affected devices in their inventory using the provided lot numbers and consult Atrium Medical Corporation for updated guidance.
The recalled product
- Product
- Express Mini 500 Dry Seal Chest Drain, Part Number 16400
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drains
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)
- UDI-DI: 00650862164008
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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