Class 3 Device Recall Stryker Flyte (surgical gown system)

• Date Initiated by Firm: December 22, 2014
• Date Posted: February 10, 2015
• Recall Status: Terminated on May 05, 2015
• Recall Number: Z-1077-2015
• Recall Event ID: 70332
• 510(K)Number: K073017
• Product Classification: Gown, surgical - Product Code FYA
• Product: Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).
• Code Information: Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E Milham Ave; Portage MI 49002-9704
• For Additional Information Contact: Julie Forsyth; 269-389-2458
• Manufacturer Reason for Recall: A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have read 2014-12-01.
• FDA Determined Cause: Error in labeling
• Action: Stryker sent an Urgent Medical Device Recall Notification letter dated December 22, 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and responding to the formal recall notification. Customers were instructed to do the following: 1. Immediately review this Recall Notification 2. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in their inventory. Complete and return the BRF even if they do not have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in this Notification. 4. If customers further distributed this product, they were instructed to forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. Completed Business Reply Forms should be faxed to 866-521-2762. Upon receipt of the Business Reply Form, Stryker will email a pre-paid shipper. This shipper can be used to return the recalled Flyte Toga(s) to Stryker. Upon receipt of the recalled Flyte Toga(s), credit will be applied to the customer's account. For questions regarding this recall customers were instructed to contact Stryker Instruments: Monday-Friday 8am-5pm (EST) at 269-389-2458. For questions regarding this recall call 269-389-2458.
• Quantity in Commerce: 1530 units (170 cases)
• Distribution: Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FYA