FDA Medical Device Recalls (openFDA)
Master & Frank (Pinghu) Co., Ltd.: 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.
- Recall number
- Z-3079-2017
- Recalling firm
- Master & Frank (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.
- Status
- Open, Classified
- Initiated
- 2017-06-01
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- 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
- 2,160 units
- Distribution
- Domestic: IL.
- Lot, serial or model codes
- Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH
- 510(k) numbers
- ["K964142"]
- PMA numbers
- not on file
- Product code
- FYA
- Firm FEI
- 3006973666
- Firm city
- Hangzhou
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28