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Open, Classified

Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX PI CVC 7F, 3L, 20CM BUNDLE ECVC6915A ECVC6985B

FDA Recall Z-2439-2026 · Posted 2026-06-12

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2026-04-27
Product Quantity49,654 kits total

Reason for Recall

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Firm Action

Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution. OUS distribution pending.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K213481Medline General Surgery TrayMedline Industries, Inc. · 2022-05-24

Official Source

View FDA Recall →

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

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