T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the mem

FDA device recall Z-1809-2012 · posted 2012-06-14 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

Reason for recall

The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.

Action taken

Stryker sent the May 29,2012 URGENT MEDICAL DEVICE RECALL NOTIFICATION and the June 14, 2012 REVISED URGENT MEDICAL DEVICE RECALL Notice to all consignees. The letters identified the affected products, problem and actions to be taken. The Revised letter instructed customers to find, quarantine, make product unusable and destroy all implicated product . Replacement products may not immediately available. Customers were asked to complete and sign the Business Reply Form (BFR) and fax to Stryker Instruments Regulatory Department at 866-521-2762. If the affected products have been further distributed, forward this notification letter and the attached BRF to all affected locations. Questions should be addressed to Angela Ragainis, 269-389-4354; angela.ragainis@stryker.com

Root cause

Process control

Status

Terminated

Product code

FYA

Quantity affected

23,653 ( past 3 years) 47937 all years

Distribution

Worldwide Distribution - US (nationwide) including the states of: AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN

Date initiated

2012-06-01

Date posted

2012-06-14

Date terminated

2014-04-14

Location

Portage, MI

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