FDA Medical Device Recalls (openFDA)
Stryker Sustainability Solutions: REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
- Recall number
- Z-2405-2024
- Recalling firm
- Stryker Sustainability Solutions
- Product
- REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
- Status
- Open, Classified
- Initiated
- 2024-05-31
- Posted
- 2024-07-17
- Terminated
- not on file
- Reason
- Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
- Root cause
- Employee error
- Action
- On June 14, Stryker Sustainability Solutions issued a "Urgent: Medical Device Recall" Notification to affected consignees via mail. Stryker ask consignees to take the following actions: 1) Please check your inventory for the devices from the affected lots and remove them from their point of use. a. 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 to Email: SSSPFA@stryker.com This form must be completed and returned to Stryker even if no affected product is found. 2) Maintain awareness of this communication internally until all required actions have been completed within your facility. 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.
- Quantity
- 90 units
- Distribution
- US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.
- Lot, serial or model codes
- Lot: 0000564862/ UDI: 00885825015411
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KCY
- Firm FEI
- 3009350690
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28