Z-3079-2017 Class II Ongoing
FDA device recall Z-3079-2017 was initiated by Master & Frank (Pinghu) Co., Ltd. on June 1, 2017 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 2,160 units.
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