FDA Devices Moderate Class II Ongoing

Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSCOPY PACK-LF, Pack Number DYNJ23150J; 4) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 5) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 6) ARTHROSCOPY TRAY, Pack Number DYNJ46435A; 7) KNEE ARTHROSCOPY PACK, Pack Number DYNJ50120D

Reported: April 2, 2025 Initiated: February 11, 2025 #Z-1452-2025

Product Description

Reason for Recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Details

Recalling Firm: MEDLINE INDUSTRIES, LP - Northfield
Units Affected: 186 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Location: Northfield, IL

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 2, 2025. Severity: Moderate. Recall number: Z-1452-2025.

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Product Description

Reason for Recall

Details

Frequently Asked Questions

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