Z-1642-2023 Class II Ongoing
FDA device recall Z-1642-2023 was initiated by Maquet Medical Systems USA on May 18, 2023 and is designated Class II. Reason for recall: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. … The recall status is ongoing. Affected quantity: 0 (US).
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2023
- Initiation Date
- May 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0 (US)
Product Description
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Reason for Recall
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Distribution Pattern
Domestic distribution nationwide.
Code Information
Model Item No. UDI-DI VKMO 10000-USA 701070441 4058863153841 VKMO 11000-USA 701070445 4058863153889 All lots