Recall Z-2592-2021 ยท KDQ Bottle, Collection, Vacuum
Atrium Medical Corporation
Atrium Pneumostat Chest Drain Valve, Part Number 16100
| Date | Aug 26, 2021 |
| Status | Open, Classified |
| Reason | The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died. |
| Root cause | Under Investigation by firm |
| Action | On August 26, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that Atrium/Getinge is in the process of updating the Instructions for Use. In the meantime, the following information was provided: REVISED Indication for Use: Pneumostat is indicated for use with adult patients in a variety of medical conditions in which evacuation of air with or without ancillary fluid is required from the pleural cavity and is also designed to facilitate ambulation. These medical conditions may include pneumothorax, thoracic injury, and other related |
| Quantity | 92,430 units |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984496 | ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN Atrium Medical Corp., May 5, 1999 |