MEDLINE 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.
FDA Recall Z-3079-2017 · Posted None
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Recalling FirmMaster & Frank (Pinghu) Co., Ltd.
Recall StatusOpen, Classified
Product CodeFYA
Date Initiated2017-06-01
Product Quantity2,160 units
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.
Firm Action
Master & 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.
Root Cause
Other
Distribution Pattern
Domestic: IL.
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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