Reported Apr 5, 2023 · Ongoing
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single…
Stryker Sustainability Solutions
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
5921-030-135 | Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect |
5921-030-235 | Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect |
5921-034-135 | Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect |
5921-034-235 | Color Cuff Dual Port, Single Bladder 34 (Purple), Quick Connect |
5921-218-135 | Color Cuff Single Port, Single Bladder 18 (Red), Quick Connect |
5921-218-235 | Color Cuff Dual Port, Single Bladder 18 (Red), Quick Connect |
- Lot codes and dates
- REF/UI-DI
5921-030-135/8858250161425921-030-235/8858250161665921-034-135/8858250161735921-034-235/8858250161975921-218-135/8858250165005921-218-235/885825016296
- Lots
226 of 226 codes
00002027750000209215000020213700002013800000200708138723221345377200001982350000202066000020942000002064250000192978000020257700001924651346334700002045780000193181000019844600002089490000195337000020626300001931791348661300002027770000195071000020415900001959120000200905000020644200001978691359448600001929790000200706000019506800002013790000199502000019943400001888631349368300001931770000202065000020071200002002420000202138135828640000195075135708320000199808000020207500001953400000200254000020293213774680138514721363470400001998190000204319000020416000002013780000200227
- REF/UI-DI
- Amount recalled
- 127,894
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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