Ocean Chest Drains Recalled for Inadequate Assembly Instructions
Atrium Medical recalls Ocean chest drains due to insufficient precaution instructions for proper catheter and tube connection setup. Improper assembly could compromise device function.
What this means for you
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 risk-of-harm medical device where inadequate instructions could lead to improper setup. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High). No hospitalization reports or injuries are mentioned in the source.
Plain-English summary
Atrium Medical Corporation is recalling the Ocean water seal chest drain system with the following product codes: 2002-000, 2002-040, 2002-100, 2002-300, 2002-400, 2012-320, and 2050-000.
The reason for the recall is that the Instructions for Use (IFU) do not provide sufficient precaution instruction for proper setup of catheters and patient tube connections with single collection chamber chest drains.
The recall affects 31,270 total cases, with 29,942 cases distributed in the United States and 1,328 cases distributed internationally. All products manufactured on or after July 21, 2020, and shipped on or after August 6, 2020, are affected.
Affected individuals should contact Atrium Medical Corporation with any questions or concerns regarding proper device setup and use.
The recalled product
- Product
- Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ;
- Manufacturer
- Atrium Medical Corporation
- Hazard
- improper-setup
- inadequate-instructions
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 (12)
- 1)2002-000 DRAIN
- OCEAN SINGLE W/AC
- S 20650862100017 (2)2002-040 DRAIN
- OCEAN SINGLE
- PEDI CONNECTOR 20650862100345 (3)2002-100 DRAIN
- OCEAN SINGLE W/AC 20650862100093 (4)2002-300 DRAIN
- OCEAN SINGLE W/S 20650862100109 (5) 2002-400 DRAIN
- OCEAN SINGLE 20650862100215 (6)2012-320 DRAIN
- OCEAN PEDI W/S 20650862101021 (7)2050-000 DRAIN
- OCEAN BRU W/AC
- 2020 Distribution Dates: Any product shipped on and after August 6
- 2020
Distribution
Distributed nationwide across the United States.
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