Medline Industries, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2980-2018)

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:

LASER CDS

Product Classification:

Class II

Date Initiated: April 12, 2017

Date Posted: September 12, 2018

Recall Number: Z-2980-2018

Event ID: 78411

Reason for Recall:

Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep" (kit component numbers: 29183, 52115, 82279, and 82281). The non-sterile components 29183, 52115, 82279, and 82281 should have been placed inside the sterile portion of the pack, where it would subsequently be exposed to the ethylene oxide sterilization process. However, the components were not placed in the sterile portion of the pack during assembly and were never exposed to the sterilization process. Components 29183, 52115, 82279, and 82281 were inadvertently released non-sterile. The remainder of the pack components were properly sterilized and only components 29183, 52115, 82279, and 82281 were affected. Components 29183, 52115, 82279, and 82281 are manufactured by Becton, Dickinson (BD) and are labeled "ChloraPrep". ChloraPrep" applicators contain 2% w/v chlorhexidine gluconate (CHG) in 70% v/v isopropyl alcohol (IPA). The applicators are used to facilitate skin preparation for various preoperative and pre-injection procedures.

Status: Terminated

Product Quantity: 144 kits

Code Information:

Model: CDS980970D; Lots: 16FD2090, 16GD2340, 16ID0038, 16KD1940, 17BD1440, 17CD2208

Distribution Pattern:

CA, NM

Voluntary or Mandated:

Voluntary: Firm initiated