Medline Industries, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2977-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

PICC Tray, STERILE, 12 packs each per case.

Product Classification:

Class II

Date Initiated: April 12, 2017

Date Posted: September 12, 2018

Recall Number: Z-2977-2018

Event ID: 78411

Reason for Recall:

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.

Status: Terminated

Product Quantity: 144 kits

Code Information:

Item number: DYNJ49177C. Lots: 16HB4700, 16UB5076, 17MB6837

Distribution Pattern:

CA, NM

Voluntary or Mandated:

Voluntary: Firm initiated