QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-
Summary
The FDA issued a Class II for QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model by Maquet Medical Systems USA. Reason: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure .
Details
Source
Device Recall
External ID
Z-1657-2023
Action Date
2023-06-07
Status
Ongoing
Category
device
Product Description
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895
Lot/Code Info: Model Item no. UDI-DI BEQ-HMO 50000-USA 701067905 4058863019079 HMO 50000-USA 701067891 4058863019055 HMO 51000-USA 701067895 4058863019185 All lots
Quantity Affected: 1,784 (US)
Reason for Recall
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Distribution
Nationwide domestic distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-18
Company
Wayne, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Maquet Medical Systems USA has 36 FDA actions in our database, including 36 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Medical Systems USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Medical Systems USA have FDA actions?
Maquet Medical Systems USA has 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1657-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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