FDA Device Recall Z-1082-2024

Windstone Medical Packaging, Inc. · Billings, MT

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.

Device

Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO

Lot / serial / GTIN: UDI: B098AMS130430/Lot #s: 178114 187325 191102 195504 196502 197864

Quantity: 475 kits

Reason for recall

Sterility assurance for saline included in surgical kits cannot be guaranteed.

Recall record

Recall number: Z-1082-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US: FL, IL, CA OUS: None
Recall initiated: 2023-12-22
Classified by FDA Center: 2024-02-16
FDA published: 2024-02-28
Recalling firm: Windstone Medical Packaging, Inc.
Firm location: Billings, MT

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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