Medical device recalls Moderate risk

Medline Pacer Implant Pack recalled over sterility concerns

Recall date
October 15, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
MEDLINE INDUSTRIES, LP - Northfield recalls (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ9…
Recall number
Z-0533-2025
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

(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.

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