Color Cuff Single Port recall
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;
Why was Color Cuff Single Port 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, 0000196363, 13392486, 13280380, 0000192981, 0000198461, 0000196361, 0000200244, 0000203310, 0000200229, 13398036, 13352572, 0000194232, 0000200253, 0000198245, 0000202776, 0000197373, 0000187746, 13765829, 13449838, 0000200256, 0000202145, 0000198246, 0000198236, 0000204574, 0000202143, 0000194242, 13583025, 0000202074, 0000203315, 0000195073, 0000193176, 0000212764, 0000196379, 13811283, 13605685, 0000187310, 0000208444, 0000204366, 0000197867, 13865381, 13820702, 0000176566, 13663274, 0000196365, 0000210787, 0000206440, 0000193391, 0000201391, 0000193412, 0000177131, 13883084, 0000198460, 0000208345, 0000206443, 0000192466, 0000210962, 0000200230, 0000204570, 13339407, 0000204314, 0000211530, 0000209200, 0000196359, 0000210005, 0000201840, 0000205922, 0000192980, 0000205238, 0000195335, 0000206518, 0000195067, 0000203313, 0000193393, 0000206254, 0000208440, 0000202686, 0000198244, 0000203314, 0000195069, 0000208407, 0000206432, 13632837, 0000210465, 0000206505, 0000172873, 0000195338, 0000199805, 0000208321, 0000195343, 0000205241, 0000200707, 0000199807, 0000195076, 0000197375, 0000203312, 13870728, 0000202139, 0000206511, 0000193392, 13824462, 0000195070, 0000199816, 0000208410, 13871893, 0000199503, 0000206586, 13272167, 13399919, 0000195072, 0000199817, 0000192977, 0000197872, 0000186596, 0000208322, 13573489, 0000209992, 0000202684, 0000211154, 0000201837, 0000210310, 0000197870, 0000208606, 0000204571, 13883045, 0000197376, 0000194228, 0000204195, 0000198237, 0000212878, 0000209416, 0000210963, 0000210601, 0000200711, 0000194229, 0000204372, 0000196362, 13807840, 0000210008, 0000200228, 0000172314, 0000200257, 0000194230, 0000205930, 0000193839, 0000193178, 0000210313, 0000198459, 13814050, 0000202144, 0000193413, 0000195336, 13765599, 0000208951, 0000195078, 0000194227, 0000193838, 0000193840, 0000202778
- 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;
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 127,894
- Distribution
- US: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE, MI, LA, OK, SD, AL, VA, MS, WV, AZ, KY, IL, AR, ME, ND, MO, KS, HI, NH, AK, TN, IA, MN, IN, NV, MA, ID, DE, NM, WY, DC, VT, CT
- Recall date
- April 5, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)