Laerdal Medical (Suzhou) Co., Ltd. Recall 86702
Description: Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
Laerdal Medical (Suzhou) Co., Ltd. Recall 86702 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0868-2021 |
| Event ID | 86702 |
| Event Description | Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| Quantity | 5035 |
| Recall Reason | Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user. |
| Device Classification | 20210127 |
| Device Code Info | Serial number range 1808090001 to 2006060045 |
| Center Classification Date | 20210115 |
| Recall Initiation Date | 20201218 |
| Recalling Firm | Laerdal Medical (Suzhou) Co., Ltd. |
| Initial Notification | Letter |
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