Device 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.
Z-3079-2017
Product summary
- Event
- Event 77633
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,160 units
- Official record key
device-enforcement:Z-3079-2017
Official wording
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.
Code information: Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH
Distribution pattern: Domestic: IL.
Derived failure modes
-
Unknown
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.