FDA Device Recall Z-0710-2024

Maquet Cardiovascular, LLC · Wayne, NJ

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit

Lot / serial / GTIN: UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952

Quantity: (7,501 cases/45,006 devices US); no OUS

Reason for recall

Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.

Recall record

Recall number: Z-0710-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
Recall initiated: 2023-12-13
Classified by FDA Center: 2024-01-12
FDA published: 2024-01-24
Recalling firm: Maquet Cardiovascular, LLC
Firm location: Wayne, NJ

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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