Skip to content
Recall Observatory FDA recall evidence

Device product

Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

Z-1642-2023

May 18, 2023

Class II

Product summary

Firm
Maquet Medical Systems USA
Event
Event 92003
Status
Ongoing
Classification
Class II
Quantity
0 (US)
Official record key
device-enforcement:Z-1642-2023

Official wording

Reason: 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.

Code information: Model Item No. UDI-DI VKMO 10000-USA 701070441 4058863153841 VKMO 11000-USA 701070445 4058863153889 All lots

Distribution pattern: Domestic distribution nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.