Z-0629-2016Class II

Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135...

Name: Z-0629-2016 Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135...
Creator: Stryker Sustainability Solutions
Published: 2015-12-17
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2015-12-17 / Terminated / root cause: labeling and UDI

FDA source

Stryker Sustainability Solutions began a recall of Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236... on 2015-12-17. FDA classified it as Class II and gives the reason as "Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0629-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-17
Posted: 2016-01-12
Terminated: 2016-07-14
Recalling firm: Stryker Sustainability Solutions
Product: Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities.
Product code: KCY Tourniquet, Pneumatic
Reason for recall: Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm sent out customer notification letters on 12/17/15. The firm requests that customers discontinue the use of the affected lots of the recall product, and other Pressure Tourniquet Cuffs reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped to the customer is included with the notification. The firm states to complete the Recall Effectiveness Check Form and indicate if any devices from the affected lots remain in inventory. The letter states the form needs to be completed even if no product is found. If the form indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433X5555 - http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
Quantity in commerce: 450 devices
Distribution: Nationwide Distribution including the states of AK, NV, VT, FL, CA, CO, WI, IA, MN, OK, PA, MI, OR, KY, and MA.
Product codes and lots: Model #5921-218-135 Lot #3490521 Model #5921-034-235 Lot #3531111 Model #5921-034-135 Lot #3733336, 4002152 Model #5921-044-135 Lot #3759409 Model #5921-024-236 Lot #3822485

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0629-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0629-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)