Z-3079-2017 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2017
- Initiation Date
- June 1, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,160 units
Product Description
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 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.
Distribution Pattern
Domestic: IL.
Code Information
Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH