Medical device recalls Moderate risk

MEDLINE INDUSTRIES, LP - Northfield recalls Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.

Recall date
October 15, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0534-2025
FDA classification
Class II
Brand / firm
MEDLINE INDUSTRIES, LP - Northfield
Sold / distributed
US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.

Why it was recalled

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.

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