Z-0593-2020Class II

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect...

Name: Z-0593-2020 Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2019-11-06
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2019-11-06 / Terminated

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2019-11-06. FDA classified it as Class II and gives the reason as "There is a potential for the cuff to leak air leading to a loss of vascular occlusion". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0593-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-06
Posted: 2019-12-02
Terminated: 2021-11-19
Recalling firm: Stryker Corp.
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.
Product code: KCY Tourniquet, Pneumatic
Reason for recall: There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
FDA root cause: Under Investigation by firm
Action: 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 [email protected]. 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.
Quantity in commerce: 16,380 total
Distribution: 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.
Product codes and lots: GTIN: 37613154599296, Lot Numbers 60180374, 60181194

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0593-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0592-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-11	2019-12-02
Z-0593-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-11	2019-12-02

Product code KCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)