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Color Cuff recallZ-1339-2023 · Stryker Corporation · initiated Mar 1, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1339-2023
Status
Open, Classified
Initiated by the company
Mar 1, 2023
Posted by the FDA
Apr 4, 2023
Recalling firm
Stryker Corporation
Quantity
1225 units (packs of 10)
Product code
KCY
Distribution
US Nationwide distribution.

Product description

Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities

Code information (models, lots, serial numbers)

GTIN: 07613327606157 Lot Numbers; 2022111803 2022112901 2022121911 2022121912 2022122601 2022122602

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 91849).

Sources and updates

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