Master & Frank (Pinghu) Co., Ltd.: Medical Device Recall in 2017 - (Recall #: Z-3079-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 1, 2017

Date Posted: September 6, 2017

Recall Number: Z-3079-2017

Event ID: 77633

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.

Status: Ongoing

Product Quantity: 2,160 units

Code Information:

Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH

Distribution Pattern:

Domestic: IL.

Voluntary or Mandated:

Voluntary: Firm initiated