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Terminated

Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa

FDA Recall Z-1623-2017 · Posted None

Recalling FirmResource Optimization & Innovation Llc
Recall StatusTerminated
Product CodeLRO
Date Initiated2017-01-09
Date Terminated2018-09-28
Product Quantity150 kits

Reason for Recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Firm Action

ROi sent an Urgent Recall Notice dated January 9, 2017, to all affected consignees. The recalling firm instructed consignees to quarantine affected product and complete the response form. The recalling firm stated that they will issue over lableing for the affected packs. Sterile replacement light covers will be sent directly to the end user if available. Consignees were instructed to inform their subaccounts of the recall. For questions regarding this recall call 417-820-2793.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Distribution to LA and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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