Z-0664-2022Class II

REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder

Name: Z-0664-2022 REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Creator: Stryker Sustainability Solutions
Published: 2022-01-21
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2022-01-21 / Terminated / root cause: labeling and UDI

FDA source

Stryker Sustainability Solutions began a recall of REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder on 2022-01-21. FDA classified it as Class II and gives the reason as "Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs". 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-0664-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-21
Posted: 2022-02-22
Terminated: 2025-02-26
Recalling firm: Stryker Sustainability Solutions
Product: REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Product code: KCY Tourniquet, Pneumatic
Reason for recall: Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On February 4, 2022, Stryker issued an "Urgent: Medical Device Recall notification" to all affected customers. In addition to informing consignees about the recalled product, the firm ask customers to take the following actions: 1.) Please check your inventory for the devices from the affected lot and remove them from their point of use. 2.) Please complete the Urgent Medical Device Recall Business Reply Form (page 3) and indicate if any of the affected product remains in your inventory. Please return this completed form through one of the following methods: a. Email: [email protected] b. To your Stryker s Sustainability Solutions Sales Representative c. Fax: 480-763-5345 This form must be completed and returned to Stryker even if no affected product is found. 3.) Maintain awareness of this communication internally until all required actions have been completed within your facility. If any of the affected products have been forwarded to additional facilities (including but not limited to distribution warehouses), please contact these facilities and communicate this recall to them. Please instruct these facilities to complete the Business Reply Form (page 3) and return the completed form either via email to [email protected], to their Stryker s Sustainability Solutions sales representative, or via fax to 480-763-5345. Alternatively, provide contact details so Stryker can inform the recipients appropriately. If the form indicates that any affected product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for all devices that are returned prior to May 1st, 2022. 4.) Adverse reactions or quality problems experienced with the use of this product should be reported to: " Stryker s Sustainability Solutions Complaint Hotline: +1-888-763-8803 " http://www.stryker.com/productexperience " The FDA s MedWatch Adverse Event Reporting program either online, by
Quantity in commerce: 40 units
Distribution: US: KS OK TX OUS: None
Product codes and lots: Lot # 12983349

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0664-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0664-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-22

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)