Home › Device types › IMD
Pack, Hot Or Cold, Disposable
FDA product code IMD · Class 1 · Physical Medicine
0
Registered devices
4,470
Adverse events
26
Recalls
82
510(k) clearances
Devices with this code
36M - State of Colorado DOT - Med Facility — Certified Safety Manufacturing, Inc.FAC-4 - Miller & Long Concrete — Certified Safety Manufacturing, Inc.75V - UP Facilities — Certified Safety Manufacturing, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCGreen GuardInstant Cold Pack — GreenguardOrthoCor Medical — Caerus Corp.Halyard — OWENS & MINOR DISTRIBUTION, INC.HAWK Warming Grid — Safeguard US Operating, LLCCuraplex — BOUND TREE MEDICAL, LLC36M - Class A Select - Metal — Certified Safety Manufacturing, Inc.BeKoool — KOBAYASHI CONSUMER PRODUCTS, LLCDISPOSABLE HOT OR COLD PACK COVER — Hangzhou A-Tek Medical & Textiles Co., Ltd.MEDLINE — MEDLINE INDUSTRIES, INC.Halyard — O&M HALYARD, INC.Sammons Preston — Performance Health Supply, LLCHAWK Responder Carrier Set — Safeguard US Operating, LLCThermaCare HeatWraps — PFIZER INC.CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDThermaCare HeatWraps — PFIZER INC.Sports Bag - Fanny Pack — Certified Safety Manufacturing, Inc.16PW - Century Link - Poly Green — Certified Safety Manufacturing, Inc.HCS — Concordance Healthcare Solutions LLCMedline — MEDLINE INDUSTRIES, INC.Pure Comfort Prostate Patch — HOME AIDE DIAGNOSTICS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-27 | Safeguard US Operating LLC | Incorrect expiration date. |
| 2024-08-27 | Safeguard US Operating LLC | Incorrect expiration date. |
| 2024-08-27 | Safeguard US Operating LLC | Incorrect expiration date. |
| 2021-11-29 | Philips North America Llc | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie |
| 2021-11-29 | Philips North America Llc | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie |
| 2021-11-29 | Philips North America Llc | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie |
| 2021-11-26 | Philips North America Llc | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie |
| 2019-07-08 | CooperSurgical, Inc. | 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 an |
| 2019-04-26 | PF Consumer Healthcare 1 LLC | There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with incr |
| 2019-04-26 | PF Consumer Healthcare 1 LLC | There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with incr |
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