Class II — Master & Frank (Pinghu) Co., Ltd.
| Recalling firm | MASTER & FRANK (CAMBODIA) CO., LTD. |
|---|---|
| Registered facility | MASTER & FRANK (CAMBODIA) CO., LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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. |
| Quantity | 2,160 units |
| Distribution | Domestic: IL. |
| Initiated | 2017-06-01 |
| Classified | 2017-08-28 |
| Recall number | Z-3079-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Master & Frank (Pinghu) Co., Ltd. (Z-3079-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77633/
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