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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Gown Poly W/Breath Sleeves

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 Class 2 Device Recall Medline Gown Poly W/Breath Sleevessee related information
Date Initiated by FirmNovember 29, 2023
Date PostedJanuary 11, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0711-2024
Recall Event ID 93560
510(K)NumberK182172 
Product Classification Gown, surgical - Product Code FYA
ProductMedline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Code Information Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.
FEI Number 1417592
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
886-359-1704
Manufacturer Reason
for Recall		Surgical gowns were manufactured with the wrong sleeve.
FDA Determined
Cause 2		Process control
ActionThe recalling firm issued letters dated 11/29/2023 via email and first class mail on 11/29/2023. The letter explained the reason for recall and provided required actions. Those actions were to (1) Immediately check the stock for the affected item and lot numbers which can be located within the recall portal; (2) Use the link and information in the letter to complete the response form; and (3) Destroy any affected inventory and the recalling firm will issue a credit. If the consignee is a distributor or has resold or transferred the product to another company or individual, the consignee is to notify the downstream company.
Quantity in Commerce2,100 gowns
DistributionDistribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.
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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