—#118581

Product

Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

FDA product code: FYA — Gown, Surgical
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K070078
Affected lot / code info: 1006130, 1101034, 1006134, 1102133, 1007151, 1103208, 1007170, 1104297, 1009205, 1105360, 1010228, 1106476, 1010260, 1107569, 1011296, 1108676, 1012336, 11097861006141, 1012303, 1102110, 1104324, and 1108664.

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: USA Nationwide Distribution

Timeline

Recall initiated: 2013-05-23
Posted by FDA: 2013-06-06
Terminated: 2014-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118581. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.