Z-3079-2017Class II

MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile...

Name: Z-3079-2017 MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile...
Creator: Master & Frank (Pinghu) Co., Ltd.
Published: 2017-06-01
License: https://open.fda.gov/license/

Principle & Will Biotech (Pinghu) Co., Ltd. / initiated 2017-06-01 / Open, Classified

FDA source

Master & Frank (Pinghu) Co., Ltd. began a recall of MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand... on 2017-06-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3079-2017
Classification: Class II
Status: Open, Classified
Initiated: 2017-06-01
Posted: 2017-08-28
Recalling firm: Principle & Will Biotech (Pinghu) Co., Ltd.
Product: 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.
Product code: FYA Gown, Surgical
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 root cause: Other
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.
Quantity in commerce: 2,160 units
Distribution: Domestic: IL.
Product codes and lots: Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3079-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3079-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-09-06	2017-08-28

Product code FYA

K964142Class IIMedline Disposable Surgical Drapes and GownsMedline Industries, Inc. / cleared 1997-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)