Surgical Gown

Model: 95221, Affected: All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008*** to AH1364***, AH2006*** to AH2146***

Lot 1091001014

Coat

Lot 1081001044

Coat

Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV.

Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).

OEM Catalog number 408-800;

General Hospital and Personal Use Devices

2

No

Distributed in DC and the states of CO, CA, FL, TX, and AR.

Medical Device Exchange Surgical Gown - Flyte Hood || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 408-800 || EXP (repackager) Stryker (OEM) || Person protection during surgery.