—#178020

Product

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.

FDA product code: KCY — Tourniquet, Pneumatic
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: GTIN: 37613154599296, Lot Numbers 60180374, 60181194

Why it was recalled

There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Urgent Medical Device Recall Notification letters dated 11/6/19 were sent to customers. Actions to be taken: 1. Immediately review this Recall Notification and the Business Reply Form. 2. Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any Color Cuff Disposable Tourniquet Cuffs identified in this Notification. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Return the completed BRF via fax (8665212762) or email to kara.spath@stryker.com. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward copies of this Notification and the BRF to all affected locations, for each location to complete and return. Even if you have distributed all product to another location, please complete a BRF and indicate each location that received product. 5. If the BRF for your facility indicates that recalled product is currently on hand, a shipping label will be provided which should be used to return recalled product. Upon receipt of the recalled product, a credit will be applied to your account.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.

Timeline

Recall initiated: 2019-11-06
Terminated: 2021-11-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.