| Class 2 Device Recall TransWarmer | |
Date Initiated by Firm | July 08, 2019 |
Create Date | August 24, 2019 |
Recall Status1 |
Terminated 3 on May 28, 2020 |
Recall Number | Z-2364-2019 |
Recall Event ID |
83110 |
510(K)Number | K934631 |
Product Classification |
Pack, hot or cold, disposable - Product Code IMD
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Product | TransWarmer Warming Infant Transport Mattress, Model no. 20421
Product Usage:
The TransWarmer Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold stress is a concern. The patented WarmGel heats up to 104 (when starting from 75 ) in 60 seconds or less. The product is sold in boxes of 6 Infant Transport Mattresses per box. The intended use of the product is to provide warmth during infant transport within the hospital or between hospitals. |
Code Information |
IJ780, IJ782, IJ785, IJ789, IJ794, IJ796, IJ804, IJ807, IJ817, IJ824, IJ832, IJ834, IJ841, IJ853, IJ865, IJ874, IJ878, IJ884, IJ886, IJ892, IJ895, IJ897, IJ900, IJ902, IJ909, IJ917, IJ920, IJ924, IJ933, IJ946, IJ948, IJ957, IJ962, IJ973, IJ976, IJ982, IJ985, IJ999, IK007, IK009, IK015, IK028, IK038, IK041, IK053, IK060, IK066, IK095, IK102, IK107, IK127, IK135, IK147, IK162, IK164, IK171, IK178, IK184, IK201, IK214, IK238, IK252, IK258, IK265, IK270, IK276, IK298, IK318, IK322, IK330, IK332, IK339, IK353, IK361, IK378, IK384, & IK390 |
Recalling Firm/ Manufacturer |
CooperSurgical, Inc. 95 Corporate Dr Trumbull CT 06611-1350
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For Additional Information Contact | Customer Service 203-601-9818 |
Manufacturer Reason for Recall | The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products do not contain the updated IFU. |
FDA Determined Cause 2 | Error in labeling |
Action | On July 8, 2019, the firm began notifying customers of the recall via Urgent Medical Device Correction letters. The letters informed customers that CooperSurgical has updated the IFU to clarify that use of the Transwarmer Mattress with other heat producing devices, such as an incubator, is prohibited. Such use could lead to serious health consequences, such as skin burns. Customers were provided with an updated version of the IFU.
Customers were asked to complete and return the acknowledgement and receipt form to the firm.
If you have any questions about this recall, please contact CooperSurgical at 203-601-5200 ext. 3300. |
Quantity in Commerce | 49813 |
Distribution | Worldwide Distribution - US Nationwide in all 50 states. International distribution to Australia, Brazil, Canada, Ecuador, Germany, Gibraltar, India, Ireland, Kuwait, Macedonia, New Zealand, Oman, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, South Korea, Switzerland, United Arab Emirates, & United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = IMD
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