FDA Device Recall Z-1326-2024

Fresenius Medical Care Holdings, Inc. · Waltham, MA

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

stay-safe /Luer Lock Catheter Ext. 18 in

Lot / serial / GTIN: Model Number: 050-95005; UDI/DI (Bag): 00840861100798; UDI/DI (Case): 10840861100795; All lots.

Quantity: 479,978 eaches

Reason for recall

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

Recall record

Recall number: Z-1326-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Domestic: Nationwide Distribution.
Recall initiated: 2024-01-23
Classified by FDA Center: 2024-03-26
FDA published: 2024-04-03
Recalling firm: Fresenius Medical Care Holdings, Inc.
Firm location: Waltham, MA

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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