FDA Medical Device Recalls (openFDA)
Stryker Sustainability Solutions: Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected duration of less than 90 minutes when temporary exsanguination of a limb is desired.
- Recall number
- Z-1802-2020
- Recalling firm
- Stryker Sustainability Solutions
- Product
- Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected duration of less than 90 minutes when temporary exsanguination of a limb is desired.
- Status
- Terminated
- Initiated
- 2019-10-09
- Posted
- not on file
- Terminated
- 2021-01-14
- Reason
- Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
- Root cause
- Employee error
- Action
- Beginning 10/09/2019, the firm provided an "URGENT MEDICAL DEVICE RECALL" notification letter and attached Recall Effectiveness Check Form to the affected customers through the sales representatives. The notification letter instructed the customer to do the following: (1) Please check inventory for the devices from the affected lot. (2) Complete the Urgent Medical Device Recall Effectiveness Check Form (page 3) and indicate if any of the affected product remains in inventory. Return the completed form through one of the following methods: (a) email; (b) sales representative; or (c) via fax to 480-763-5345. The form must be completed and returned even if no affected product is found. 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 Recall Effectiveness Check Form (page 3) and return the completed form either via email email, sales representative, or via fax to 480-763-5345. 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 the facility for all devices that are returned prior to January 1, 2020.
- Quantity
- 90
- Distribution
- US Nationwide distribution including the states of SC, TX, UT, NY, AR
- Lot, serial or model codes
- Lot Number 10237165
- 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