Recall Z-0709-2024 ยท CAC Apparatus, Autotransfusion
Maquet Cardiovascular, LLC
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
| Date | Jan 12, 2024 (initiated Dec 13, 2023) |
| Status | Open, Classified |
| Reason | Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death. |
| Root cause | Material/Component Contamination |
| Action | On December 13, 2023, the firm notified customers through "URGENT MEDICAL DEVICE CORRECTION" letters. Customers were instructed to examine their inventory to determine if they had any affected lots of the Atrium Express Dry Suction Dry Seal Chest Drains. The correction only affects the sterile water syringe; do not use this syringe. If customers do not need visualization of active pneumothorax, they may keep the affected Express chest drain and set up without water. If customers wish to use the Express chest drain as intended, they may replace the affected sterile water syringe with a new |
| Quantity | (34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS) |
| Distribution | Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043140 | EXPRESS AND OASIS CHEST DRAIN Atrium Medical Corp., Dec 8, 2004 |