Z-2980-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 12, 2018
- Initiation Date
- April 12, 2017
- Termination Date
- August 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144 kits
Product Description
LASER CDS
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.
Distribution Pattern
CA, NM
Code Information
Model: CDS980970D; Lots: 16FD2090, 16GD2340, 16ID0038, 16KD1940, 17BD1440, 17CD2208