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U.S. Department of Health and Human Services

Class 2 Device Recall TempPad Cold Therapy Pad .

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 Class 2 Device Recall TempPad Cold Therapy Pad .see related information
Date Initiated by FirmNovember 14, 2009
Date PostedFebruary 04, 2010
Recall Status1 Terminated 3 on January 25, 2012
Recall NumberZ-0782-2010
Recall Event ID 53947
Product Classification Pack, Hot or cold, Water Circulating - Product Code ILO
ProductTempPad Cold Therapy Pad. The device is used for localized temperature therapy including hand, elbow, arm, foot, ankle, leg, or knee.
Code Information Part #: 50625, Catalog number: 510-US, Lot #: 08296, 08529, 08530, 08531, 08674, 08759, 08826, 08952, 09052, 09166, 09422, 09423; Part #: 50633, Catalog #: 510-USS, Lot #: 08537, 08675, 08953; Part #: 50627, Catalog #: 814-US, Lot #: 08610; Part # 50634, Catalog # 814-USS, Lot #: 08611, 08919, 09466; Part #: 50628, Catalog #: 1112-US, Lot #'s: 08382, 08411, 08475, 08476, 08477, 08557, 08583, 08657, 08666, 08667, 09486, 08668, 08707, 08771, 08810, 08874, 08903, 08971, 09037, 09088, 09089, 09149, 09225, 09251, 09285, 09313, 09314, 09327, 09360, 09361, 08320; Part #:50635, Catalog #: 1112-USS, Lot #'s: 08410, 08514, 08606, 08673, 08708, 08772, 08802, 08868, 08954, 09017, 09066, 09067, 09195, 09253, 09254, 09295, 09377, 09378, 09485, 08331; Part #: 50629, Catalog #: 1215-US, Lot #'s: 08395, 08584, 08669, 08732, 08917, 08989, 09107, 09218 & Part #: 50137, and Catalog #: CT-99, Lot #'s: 08332, 08353, 08438, 08538, 08607, 08608, 08706, 08725, 08773, 08837, 08851, 08879, 08933, 08970, 09010, 09086, 09087, 09143, 09144, 09157, 09294, 09329, 09362, 09379 and 08423.
Recalling Firm/
Manufacturer
Cincinnati Sub-Zero Products Inc
12011 Mosteller Rd
Cincinnati OH 45241-1528
For Additional Information ContactKristine Gilkey
513-772-8810
Manufacturer Reason
for Recall
Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured.
FDA Determined
Cause 2
Other
ActionOn November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989-7373, extension 3234 or 1-51 3-71 9-3234 for recall instructions. Representatives will be available to take your call from 8:30 a.m. until 4:30 p.m. eastern standard time, Monday through Friday.
Quantity in Commerce8,872 cartons of ten + 677 each (89,397 total)
DistributionWorldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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