FDA Device recall Z-3079-2017
MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown
- FDA Device
- Class II
- ongoing
- Published 2017-09-06
On 2017-09-06 the FDA classified a Class II recall of MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown by Master And Frank Pinghu, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3079-2017 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-06-01 |
| Published | 2017-09-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Master And Frank Pinghu |
| Distribution | IL |
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.
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.
Identifiers
| code_info | Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3079-2017%22
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