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Open, Classified

Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case

FDA Recall Z-1035-2023 · Posted 2023-01-27

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeOJH
Date Initiated2022-11-17
Product Quantity16 units

Reason for Recall

Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.

Firm Action

Medline Industries, LP notified consignees via email and first-class mail on 11/21/2022. Consignees were instructed to over-label the sterile kits with a warning label indicating Warning To Avoid Injury, Please Handle Blades with Care . For the Non-Sterile kits, they are to over label the affected kits indicating to remove the blades and replace from a different sterile supply. No product is to be returned. Customers were also instructed to complete and return the response form.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the states of AR, MD, WA, WI.

Official Source

View FDA Recall →

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

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