Recall Z-1809-2012 ยท FYA Gown, Surgical
Stryker Instruments Div. of Stryker Corporation
T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
| Date | Jun 14, 2012 (initiated Jun 1, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 dis |
| Quantity | 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, TX, VA, WA, WI, WV and the country of SWITZERLAND |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944393 | STRYKER STERI-SHIELD SURGICAL APPAREL Stryker Corp., Aug 28, 1995 |