Recall Z-1205-2017
Atrium Medical Corporation · initiated December 23, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area.
Codes / lots: Lot Number: 242896, 243292
Reason for recall
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
FDA-determined cause: Process control
Action taken
Maquet issued a Field action correction notification sent to customers on 12/23/16 via Fed'x for delivery on Tuesday Dec.27, 2016.who have received affected product and describes the failure mode. Accounts to complete the enclosed Field Notification Reply Form to acknowledge receipt of the notification. Return the Field Notification Reply Form to the following e-mail address: drainsmvv.us@getinge.com or you may fax the form to 1-603-386-6590. Questions, contact your local Atrium/Maquet/Getinge chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST). UPDATE: On 1/16/17, Maquet issued recall letters that identified correct lot numbers and products in the letter titles: UPDATE-UPDATED AFFECTED DEVICES. Two letters issued one to customers who received the Dec 23 letter and one to new customers who who did not receive the Dec. 23 letter.
Details
- Recall number
- Z-1205-2017
- Initiated
- December 23, 2016
- Terminated
- November 3, 2020
- Product code
- KDQ – Bottle, Collection, Vacuum
- Quantity
- 245 cases (1470 units)
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
- Recalling firm
- Atrium Medical Corporation, Hudson, NH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1206-2017 Class II | Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | 12/23/2016Terminated |
| Z-1207-2017 Class II | Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference:…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | 12/23/2016Terminated |
| Z-1208-2017 Class II | Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | 12/23/2016Terminated |
| Z-1209-2017 Class II | Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | 12/23/2016Terminated |
| Z-1210-2017 Class II | Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | 12/23/2016Terminated |
| Z-1211-2017 Class II | Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | 12/23/2016Terminated |