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U.S. Department of Health and Human Services

Class 2 Device Recall ArtLine Surgery PackLF

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 Class 2 Device Recall ArtLine Surgery PackLFsee related information
Date Initiated by FirmApril 12, 2017
Create DateSeptember 06, 2018
Recall Status1 Terminated 3 on August 05, 2019
Recall NumberZ-2976-2018
Recall Event ID 78411
Product Classification unknown device name - Product Code N/A
ProductArt-Line Surgery Pack-LF, STERILE, 40 packs each per case.
Code Information Item number: DYNJ0165296D. Lots: 16CK2326; 16DK0985; 16DK2816; 16GK2433; 16IK0634; 16KK0117; 17AK1788; 17BK2514 
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 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.
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 Commerce3,000 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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