FDA Device recall Z-1315-2023
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blu…
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blu… by Stryker Sustainability Solutions, citing increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or un….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1315-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-01 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY |
Product
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135; Color Cuff Dual Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-235; Color Cuff Single Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-135; Color Cuff Dual Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-235;
Reason
Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.
Identifiers
| code_info | REF/UI-DI: 5921-030-135/885825016142, 5921-030-235/885825016166, 5921-034-135/885825016173, 5921-034-235/8…REF/UI-DI: 5921-030-135/885825016142, 5921-030-235/885825016166, 5921-034-135/885825016173, 5921-034-235/885825016197, 5921-218-135/885825016500, 5921-218-235/885825016296 Lots: 0000202775, 0000209215, 0000202137, 0000201380, 0000200708, 13872322, 13453772, 0000198235, 0000202066, 0000209420, 0000206425, 0000192978, 0000202577, 0000192465, 13463347, 0000204578, 0000193181, 0000198446, 0000208949, 0000195337, 0000206263, 0000193179, 13486613, 0000202777, 0000195071, 0000204159, 0000195912, 0000200905, 0000206442, 0000197869, 13594486, 0000192979, 0000200706, 0000195068, 0000201379, 0000199502, 0000199434, 0000188863, 13493683, 0000193177, 0000202065, 0000200712, 0000200242, 0000202138, 13582864, 0000195075, 13570832, 0000199808, 0000202075, 0000195340, 0000200254, 0000202932, 13774680, 13851472, 13634704, 0000199819, 0000204319, 0000204160, 0000201378, 0000200227, 0000203311, 0000206583, 13235119, 0000194243, 0000196364, 0000193841, 0000200270, 13828088, 0000196 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1315-2023%22
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