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Open, Classified

Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505

FDA Recall Z-1433-2024 · Posted 2024-03-29

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeEPY
Date Initiated2024-02-23
Product Quantity440 units

Reason for Recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Firm Action

Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

Official Source

View FDA Recall →

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

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