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U.S. Department of Health and Human Services

Class 2 Device Recall LASER CDS

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 Class 2 Device Recall LASER CDSsee related information
Date Initiated by FirmApril 12, 2017
Create DateSeptember 06, 2018
Recall Status1 Terminated 3 on August 05, 2019
Recall NumberZ-2980-2018
Recall Event ID 78411
Product Classification unknown device name - Product Code N/A
ProductLASER CDS
Code Information Model: CDS980970D; Lots: 16FD2090, 16GD2340, 16ID0038, 16KD1940, 17BD1440, 17CD2208
FEI Number 3000717925
Recalling Firm/
Manufacturer		 Medline Industries, Inc.
1170 S Northpoint Blvd
Waukegan IL 60085-6757
For Additional Information ContactKassandra L. Cotner
847-775-6072
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionFirm 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.
Quantity in Commerce144 kits
DistributionCA, NM
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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