Z-0451-2013 Class II Terminated
FDA device recall Z-0451-2013 was initiated by Kimberly-Clark Corporation on September 16, 2010 and is designated Class II. Reason for recall: Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately. The recall status is terminated (terminated December 20, 2012). Affected quantity: 400 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 5, 2012
- Initiation Date
- September 16, 2010
- Termination Date
- December 20, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400 units
Product Description
Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Reason for Recall
Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
Distribution Pattern
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
Code Information
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