FDA Device Recall Z-2248-2023

Draeger Medical, Inc. · Telford, PA

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

Carina Sub-Acute Care Ventilator

Lot / serial / GTIN: Part No. 5704110; UDI-DI 04048675398516; All Serial No.

Quantity: 11,621 units

Reason for recall

Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.

Recall record

Recall number: Z-2248-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide Distribution.
Recall initiated: 2023-07-12
Classified by FDA Center: 2023-08-18
FDA published: 2023-08-30
Recalling firm: Draeger Medical, Inc.
Firm location: Telford, PA

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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