Oasis Water Seal Chest Drains Recalled for Inadequate Setup Instructions
Atrium Medical's Oasis Dry Suction Water Seal Chest Drains are recalled because Instructions for Use do not adequately explain proper setup of catheter and patient tube connections on single collection chamber models.
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: FDA Class II recall with no reported illnesses or injuries. The hazard involves inadequate instructions for proper setup of catheter and patient tube connections, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling specific models of Oasis Dry Suction Water Seal Chest Drains due to insufficient instructions for proper setup.
The Instructions for Use (IFU) for the Oasis chest drains do not provide sufficient guidance for properly setting up catheter(s) and patient tube connections when used with single collection chamber models. This lack of adequate precautionary instruction is the basis for the recall.
The recalled products include three models: Oasis Single with AC (3600-100), Oasis Pedi with AC (3612-100), and Oasis BRU with AC (3650-100). All units manufactured on or after July 21, 2020, are affected. Approximately 471,037 cases were distributed in the United States and 638 cases were distributed internationally.
Healthcare providers should follow guidance from Atrium Medical Corporation regarding the use of affected chest drains.
The recalled product
- Product
- Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
- Manufacturer
- Atrium Medical Corporation
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 (7)
- UDI-DI: (1)3600-100 DRAIN
- OASIS SINGLE W/AC 20650862110016
- (2)3612-100 DRAIN
- OASIS PEDI A/C 20650862111013
- (3) 3650-100 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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