Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
This recall has been terminated (originally issued November 29, 2012).
- Company
- Kimberly-Clark Corporation
- Recall Initiated
- September 16, 2010
- Posted
- November 29, 2012
- Terminated
- December 20, 2012
- Recall Number
- Z-0451-2013
- Quantity
- 400 units
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
Distribution
Nationwide Distribution including AZ, AK, CA, CO, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, MD, ME MA, MS, MO, MT, NE, NJ, NM, NV, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WV, and WI
Lot / Code Info
Serial Number - SA09043017, SA09043019, SA0904320, SA09043018, SA09043015, SA09043012, SA09043016, SA09043014, SA09043013, SA09043009, SA09043011, SA09043010, SA09043008, SA09043007, SA09043006, SA09043003, SA09043005, SA09043004, SA09043002, SA09043001, SA09020013, SA09020012, SA09020014, SA09020011, SA09020010, SA09020009, SA0902008, SA09020006, SA09020007, SA08343100, SA09020004, SA09020005, SA09020002, SA09020003, SA09020001, SA08343099, SA08343098, SA08343097, SA08343096, SA08343095, SA08343094, SA08343093, SA08343092, SA08343091, SA08343090, SA08343089, SA08343087, SA08343088, SA08343086, SA08343085, SA08343083, SA08343084, SA08343053, SA08343073, SA08288014, SA08288002, SA08343054, SA08343082, SA08343081, SA08343080, SA08343079, SA08343078, SA08343077, SA08165007, SA08343076, SA08343075, SA08343074, SA08343072, SA08343055, SA08288007, SA08343071, SA08343070, SA08343069, SA08343068, SA08343067, SA08343066, SA08343065, SA08343064, SA08343063, SA08343059, SA08343058, SA08343062, SA08343061, SA08343060, SA08343056, SA08343057, SA08288012, SA08288017, SA08288016, SA08288015, SA08288013, SA08288011, SA08288009, SA08288006, SA08288003, SA08288010, SA08288008, SA08288004, SA08288005, SA08288001, SA08165013, SA08165014, SA08165015, SA08165018, SA08165016, SA08165017, SA08165006, SA08165005, SA08165011, SA08165012, SA08165010, SA08165009, SA08165004, SA08165008, SA08165002, SA08165003, SA08144035, SA08144030, SA08165001, SA08144034, SA08144033, SA08144032, SA08144031, SA08144029, SA08144028, SA08144025, SA08144027, SA08144021, SA08144026, SA08144024, SA08144023, SA08144022, SA08136010, SA08136006, SA08136003, SA08136009, SA08136005, SA08136004, SA08136007, SA08136001, SA08136002, SA08136008, SA08094129, SA08094137, SA08094141, SA08094136, SA08094150, SA08094153, SA08094152, SA08094151, SA08094149, SA08094145, SA08094148, SA08094147, SA08094143, SA08094146, SA08094142, SA08094144, SA08094140, SA08094139, SA08094138, SA08094134, SA08094130, SA08094132, SA08094135, SA08094131, SA08094133, SA08094127, SA08094128, SA08094125, SA08094126, SA08094124, SA08017044, SA08017049, SA08017045, SA08017040, SA08017034, SA08017035, SA08017041, SA08017047, SA08017042, SA08017043, SA08017048, SA08017039, SA08017046, SA08017038, SA08017037, SA08017030, SA08017036, SA08017028, SA08017029, SA08017027, SA08017033, SA08017031, SA08017032, SA07344022, SA07344029, SA07344028, SA07344026, SA07344027, SA07344030, SA07344021, SA07344023, SA07344024, SA07344025, SA07320002, SA07320001, SA07320014, SA07320015, SA07320013, SA07320011, SA07320012, SA07320006, SA07320005, SA07320008, SA07320010, SA07320009, SA07320007, SA07320004, SA07320003, SA07261006, SA07257008, SA07261004, SA07261007, SA07261002, SA07257004, SA07257007, SA07257003, SA07257002, SA07261005, SA07261008, SA07261003, SA07261001, SA07257005, SA07257006, SA07257001, SA07250005, SA07250004, SA07250002, SA07250003, SA07250001, SA07228007, SA07228008, SA07228001, SA07228002, SA07228003, SA07228004, SA07228005, SA07228006, SA07180006, SA07180005, SA07180004, SA07180003, SA07180002, SA07180001, SC07171006, SC07171005, SC07171004, SC07171003, SC07171002, SC07171001
Root Cause
Component design/selection
Action Taken
Kimberly Clark sent an Urgent Field Corrective Action letter dated September 16, 2010, to all affected customers. The letter identified the product, the problem, and the aciton to be taken by the customer. Customers were asked to confirm whether their facility as the affected product by faxing the completed Field Corrective Action Response Form to 920-380-6682. Kimberly-Clark will arrange to perform the upgrade at the customer's facility. Customers with questions should call the Field Corrective Action Coordinator at 770-587-7400. For questions regarding this recall call 770-587-8393.