FDA Device Recall Z-2254-2024

Synergetics Inc · O Fallon, MO

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

BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)

Lot / serial / GTIN: UDI/DI 20841305107612, Lot Number P62764970R

Quantity: 35 units

Reason for recall

Sterilization certificates could not be validated by the supplier

Recall record

Recall number: Z-2254-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide
Recall initiated: 2024-06-12
Classified by FDA Center: 2024-07-11
FDA published: 2024-07-17
Recalling firm: Synergetics Inc
Firm location: O Fallon, MO

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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