Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PICC Tray Recalled by Medline Industries, Inc. Due to Multiple surgical packs were assembled with a non-sterile...

Date: April 12, 2017
Company: Medline Industries, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medline Industries, Inc. directly.

Affected Products

PICC Tray, STERILE, 12 packs each per case.

Quantity: 144 kits

Why Was This Recalled?

Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.

Where Was This Sold?

This product was distributed to 2 states: CA, NM

Affected (2 states)Not affected

About Medline Industries, Inc.

Medline Industries, Inc. has 18 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report