FDA recall Z-3079-2017

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 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

Domestic: IL.

Key facts

Status

Ongoing

Initiation date

2017-06-01

Report date

2017-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hangzhou, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3079-2017