Recall Z-0317-2024— Atrium Medical Corporation
Class II · Ongoing
Class II FDA medical device recall by Atrium Medical Corporation, initiated 2023-09-18. It names 2 FDA 510(k) clearances: K201305, K043140. 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;. Reason: Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
- Recalling firm
- Atrium Medical Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-18
- Firm location
- Merrimack, NH, United States
510(k) clearances named in this recall
2 on FDA's record- K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
- K043140 — EXPRESS AND OASIS CHEST DRAIN
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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;
Reason for recall
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains
Data sourced from openFDA. This site is unofficial and independent of the FDA.