Recall Z-1494-2013 ยท FYA Gown, Surgical
Stryker Instruments Div. of Stryker Corporation
Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; 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.
| Date | Jun 6, 2013 (initiated May 23, 2013) |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| Action | 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 an |
| Quantity | 21,660 units (2166 boxes) |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070078 | STRYKER T4 HYTREL TOGA Stryker Instruments, Instruments Div., Feb 2, 2007 |