LASER CDS
Recall
- Recall Number
- Z-2980-2018
- Event Number
- 78411
- Firm
- Medline Industries, Inc.
- FEI Number
- 3000717925
- Product Code
- N/A
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 12, 2017
- Terminated
- August 5, 2019
- Address
- 1170 S Northpoint Blvd, Waukegan, IL, 60085-6757
Description
LASER CDS
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.
Firm contacted customers via phone and letter beginning April 12, 2017. Customers were instructed to remove the Ethicon BioPatch Protective Disk with CHG from the kit(s) and return it to the firm. The firm would provide a sterile replacement BioPatch. Affected product will be destroyed.
CA, NM
144 kits