Recall Z-3079-2017— Master & Frank (Pinghu) Co., Ltd.

Name: FDA recall Z-3079-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-01

Class II · Ongoing

Class II FDA medical device recall by Master & Frank (Pinghu) Co., Ltd., initiated 2017-06-01. It names one FDA 510(k) clearance: K964142. 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..

Recalling firm: Master & Frank (Pinghu) Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2017-06-01
Firm location: Hangzhou, N/A, China

510(k) clearances named in this recall

1 on FDA's record

K964142 — MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSMedline Industries, Inc.·cleared 1997-02-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.