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U.S. Department of Health and Human Services

Class 2 Device Recall Sensicare Green Polyisoprene Surgical Glove with Aloe Vera, Size 8.5, MSH1285, Lot Number 7018933694

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 Class 2 Device Recall Sensicare Green Polyisoprene Surgical Glove with Aloe Vera, Size 8.5, MSH1285, Lot Number 7018933694see related information
Date Initiated by FirmOctober 23, 2017
Date PostedNovember 21, 2017
Recall Status1 Terminated 3 on April 06, 2021
Recall NumberZ-0162-2018
Recall Event ID 78464
510(K)NumberK040503 
Product Classification Surgeon's gloves - Product Code KGO
ProductSensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
Code Information Model No. MSG1285, Lot No. 701893369485
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information ContactKassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		Possible open seal on top portion of the package. Could cause breach of sterility.
FDA Determined
Cause 2		Packaging
ActionMedline Industries sent an Immediate Action Required Letter dated October 23, 2017, to all affected customers.. Instructions included to check inventory and quarantine affected product, complete and return the response form to Medline, arrange for the return of any affected product, and notify any customers if the product was further distributed. Customers with questions were instructed to call 866-359-1704.
Quantity in Commerce8,000 units
DistributionWorldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Canada.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = KGO
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