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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE SIRUS Surgical Gown, Strong Protection Surgical Gown, Surgeon

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 Class 2 Device Recall MEDLINE SIRUS Surgical Gown, Strong Protection Surgical Gown, Surgeonsee related information
Date Initiated by FirmJune 01, 2017
Create DateAugust 28, 2017
Recall Status1 Open3, Classified
Recall NumberZ-3079-2017
Recall Event ID 77633
510(K)NumberK964142 
Product Classification Gown, surgical - Product Code FYA
ProductMEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.
Code Information Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH
Recalling Firm/
Manufacturer		 Master & Frank (Pinghu) Co., Ltd.
2 No. 2000 Xingping Road
Hangzhou China
Manufacturer Reason
for Recall		The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.
FDA Determined
Cause 2		Other
ActionMaster & Frank Enterprise Co., LTD is working directly with Medline Industries, Inc., on this recall. A written notification was emailed to Medline Industries, Inc. on June 1, 2017 notifying them of the recall and further instructions. Consignee was instructed to quarantine and destroy any recalled product and to respond to the recall communication. The attached recall response form requested that the consignee notify all of their own customers of the recall.
Quantity in Commerce2,160 units
DistributionDomestic: IL.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FYA
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