Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS recalled over sterility concerns

Recall date

November 21, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF…

Recall number

Z-0779-2025

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

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

Why it was recalled

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

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 custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SHUNT PACK, REF PHS392834010D; 7) VP SHUNT, REF SYNJ10307A.