Z-1344-2023Class II

Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number...

Name: Z-1344-2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number...
Creator: Stryker Corporation
Published: 2023-03-01
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2023-03-01 / Open, Classified

FDA source

Stryker Corporation began a recall of Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures... on 2023-03-01. FDA classified it as Class II and gives the reason as "Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1344-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-01
Posted: 2023-04-04
Recalling firm: Stryker Corp.
Product: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Product code: KCY Tourniquet, Pneumatic
Reason for recall: Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
FDA root cause: Under Investigation by firm
Action: Stryker issued Urgent Medical Device Recall letter dated 2/27/23 via 2-day Fedex delivery. The purpose of this letter is to inform you of an increase in reported low pressure events for specific lots of Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs and to reiterate the steps in the Instructions For Use (IFU) to mitigate the risk to achieve or maintain pressure. Letter states reason for recall, health risk and action to take: Please review all action steps below and complete the acknowledgement section (pg.3) of this letter and return by email to [email protected]. 1. Immediately review this notification and distribute this letter internally to all users of the Color Cuff Non-Sterile Disposable Tourniquet Cuffs. 2. Follow the subsequent steps from the Instructions For Use (IFU) to mitigate the risk of the cuff not being able to achieve or maintain pressure. Following these steps, you may continue to use the product as-is. a. Prior to using the Non-Sterile Tourniquet Cuffs, please review the Safety Directives, Inspection, and Instructions sections of the IFU. To view this IFU electronically, go to https://ifu.stryker.com/XHR/129532. b. Prior to connecting the Non-Sterile Disposable Tourniquet Cuffs to the Stryker SmartPump, please review the bullet points below from pages 18-20 of the IFU for the SmartPump Tourniquet System. For troubleshooting, please refer to page 28. To view this IFU electronically, go to https://ifu.stryker.com/XHR/129013. " ALWAYS monitor pneumatic connections during use, including the cuff(s) and cuff connector(s) with O-ring, the quick-lock connectors, and the fill line(s) and connectors. If leakage or damage is apparent, see Troubleshooting. " NOTE: If a cuff does not reach or maintain the target pressure value during initial inflation, discontinue using the cuff. See To Switch (or Backup) a Single Cuff. " ALWAYS respond to an alert condition before continuing to use the tourniquet pump. An ALERT symbol, a flashing
Quantity in commerce: 1707 units (packs of 10)
Distribution: US Nationwide distribution.
Product codes and lots: GTIN: 07613327606164 Lot Numbers: 2022111802 2022112904 2022121301 2022121302 2022121905 2022121906 2022121907 2022121908

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1344-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1339-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-04
Z-1340-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-04
Z-1341-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-04
Z-1342-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-04
Z-1343-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-04
Z-1344-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-04

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)