Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
FDA Recall Z-0711-2024 · Posted 2024-01-11
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Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeFYA
Date Initiated2023-11-29
Product Quantity2,100 gowns
Reason for Recall
Surgical gowns were manufactured with the wrong sleeve.
Firm Action
The 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.
Root Cause
Process control
Distribution Pattern
Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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