—#133146

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).

FDA product code: FYA — Gown, Surgical
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K073017
Affected lot / code info: Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01

Why it was recalled

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV.

Timeline

Recall initiated: 2014-12-22
Posted by FDA: 2015-02-10
Terminated: 2015-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133146. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.