Stryker Sustainability Solutions: Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red),

Hazard

Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.

Details from the source

Reason for recall: Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure. Distribution: U.S.: 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, NE, NH, NJ, NY, OHJ, OK, OR, PA SC, SD, TN, TX, VA, VT, and WA. O.U.S.: N/A Quantity: 56,740 cuffs Lot/code info: 5921-018-135 COLOR CUFF SINGLE PORT, SINGLE BLADDER 18" (RED), QUICK CONNECT-018-135 COLOR UDI-DI code: 50885825016024 Serial/Lot Numbers: 0000608407 0000666479 0000710705 0000748402 0000779936 0000806234 0000823124 0000853520 0001026721 0001191140 0000610592 0000668978 0000713274 0000750469 0000782278 0000806424 0000823125 0000856167 0001028153 0001204019 0000613383 0000674814 0000716919 0000753840 0000784288 0000807132 0000824757 0000877820 0001033211 0001217956 0000618222 0000679061 0000720023 0000754633 0000787628 0000808365 0000827488 0000878368 0001058134 0001229508 0000628325 0000680520 0000720933 0000755710 0000788773 0000809629 0000829817 0000884047 0001072723 0001231688 0000634780 0000683417 0000726263 0000756541 0000790106 0000811248 0000831661 0000887355 0001080285 0001238396 0000645259 0000687976 0000729862 0000757389 0000790446 0000811740 0000832427 0000899094 0001087139 0001247960 0000647073 0000689032 0000734825 0000759043 0000792153 0000813049 0000833383 0000904725 0001107907 0001248642 0000649426 0000690670 0000736903 0000766311 0000793178 0000813414 0000839160 0000936850 0001109580 0000650589 0000694958 0000740521 0000770116 0000795030 0000816441 0000842177 0000950419 0001117732 0000650994 0000696012 0000741830 0000771335 0000795826 0000818289 0000843424 0000956337 0001118566 0000652336 0000697626 0000742683 0000773128 0000796587 0000819853 0000846088 0000973851 0001158477 0000658811 0000699733 0000745094 0000775812 0000800461 0000820677 0000848208 00009829

UPC codes

50885825016024, 50885825016062, 50885825016116

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.