Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and ar

FDA device recall Z-1490-2013 · posted 2013-06-06 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

Reason for recall

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Action taken

Stryker sent an Urgent Urgent Recall noitifications letter dated May 7, 2013 via certified US mail and E-mail l to all affected customers, distributors and direct accounts. The letter identified the affected products, problem, risk to health, and actions to be taken. Customers were instructed to check inventory, immediately quarantine any affected product, and open each package before discarding to prevent use. Customers were directed to fill out and return a Business Reply Form to Stericycle, Phone: 888-943-2396 Fax: 888-943-4192, Email: stryker5893@stericycle.com verifying directions and confirming recalled product was destroyed. For questions call 269-389-4354 or 269-389-4518.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FYA

Quantity affected

48,040 units, ( 4804 boxes)

Distribution

USA Nationwide Distribution

Date initiated

2013-05-23

Date posted

2013-06-06

Date terminated

2014-04-14

Location

Portage, MI

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