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TRANSWARMER INFANT TRANSPORT MATTRESS

Model 20421 · Coopersurgical, Inc. · DI 00888937025767

IMD — Pack, Hot Or Cold, Disposable · Class I · 21 CFR 890.5710

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (2)

InitiatedRecall #ClassStatusReasonLink basis
2019-07-08Z-2364-2019Class IITerminatedThe 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.k number procode
2013-05-01Z-1397-2015Class IITerminatedTrans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specificationk number procode

Adverse-event reports — MAUDE (37)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 27 · Injury: 10

25792019-01: 0 reports for this device; peer average 1.5/device2019-02: 0 reports for this device; peer average 1.13/device2019-03: 0 reports for this device; peer average 1.5/device2019-04: 2 reports for this device; peer average 1.57/device2019-05: 2 reports for this device; peer average 1.83/device2019-06: 1 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1.6/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1.6/device2019-10: 0 reports for this device; peer average 1.5/device2019-11: 0 reports for this device; peer average 1.67/device2019-12: 1 reports for this device; peer average 1.58/device2020-01: 0 reports for this device; peer average 1.25/device2020-02: 0 reports for this device; peer average 2.43/device2020-03: 0 reports for this device; peer average 1.63/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1.4/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1.67/device2020-10: 0 reports for this device; peer average 1.75/device2020-11: 0 reports for this device; peer average 1.67/device2020-12: 1 reports for this device; peer average 1.33/device2021-01: 2 reports for this device; peer average 1.5/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1.22/device2021-05: 0 reports for this device; peer average 1.78/device2021-06: 0 reports for this device; peer average 1.67/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 2.14/device2021-09: 0 reports for this device; peer average 1.25/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1.86/device2022-01: 0 reports for this device; peer average 1.33/device2022-02: 0 reports for this device; peer average 1.17/device2022-03: 1 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 1.91/device2022-05: 0 reports for this device; peer average 1.71/device2022-06: 0 reports for this device; peer average 5.25/device2022-07: 0 reports for this device; peer average 1.71/device2022-08: 0 reports for this device; peer average 6/device2022-09: 0 reports for this device; peer average 2.38/device2022-10: 0 reports for this device; peer average 3.33/device2022-11: 0 reports for this device; peer average 2.67/device2022-12: 0 reports for this device; peer average 4.25/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 2.5/device2023-03: 0 reports for this device; peer average 2.71/device2023-04: 0 reports for this device; peer average 2.14/device2023-05: 0 reports for this device; peer average 3.5/device2023-06: 0 reports for this device; peer average 5/device2023-07: 0 reports for this device; peer average 1.71/device2023-08: 0 reports for this device; peer average 3.5/device2023-09: 0 reports for this device; peer average 3.4/device2023-10: 2 reports for this device; peer average 2.67/device2023-11: 0 reports for this device; peer average 1.83/device2023-12: 0 reports for this device; peer average 6/device2024-01: 0 reports for this device; peer average 6.67/device2024-02: 3 reports for this device; peer average 4/device2024-03: 0 reports for this device; peer average 6/device2024-04: 0 reports for this device; peer average 2.75/device2024-05: 0 reports for this device; peer average 4.33/device2024-06: 0 reports for this device; peer average 3.67/device2024-07: 0 reports for this device; peer average 5/device2024-08: 0 reports for this device; peer average 2/device2024-09: 3 reports for this device; peer average 2.5/device2024-10: 0 reports for this device; peer average 1/device2024-11: 9 reports for this device; peer average 5.8/device2024-12: 3 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 2.5/device2025-02: 0 reports for this device; peer average 1.67/device2025-03: 0 reports for this device; peer average 3/device2025-04: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 4/device2025-06: 0 reports for this device; peer average 2.5/device2025-07: 0 reports for this device; peer average 3.5/device2025-08: 0 reports for this device; peer average 2.33/device2025-09: 0 reports for this device; peer average 1/device2025-10: 3 reports for this device; peer average 2.5/device2025-11: 2 reports for this device; peer average 1.5/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 2.33/device2026-02: 0 reports for this device; peer average 2.5/device2026-03: 2 reports for this device; peer average 2.5/device2026-04: 0 reports for this device; peer average 5/device2026-05: 0 reports for this device; peer average 2.25/device2026-06: 0 reports for this device; peer average 3.33/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0201.13
2019-0301.5
2019-0421.57
2019-0521.83
2019-0611
2019-0701.6
2019-0801
2019-0901.6
2019-1001.5
2019-1101.67
2019-1211.58
2020-0101.25
2020-0202.43
2020-0301.63
2020-0401
2020-0501
2020-0601.4
2020-0701
2020-0801
2020-0901.67
2020-1001.75
2020-1101.67
2020-1211.33
2021-0121.5
2021-0201
2021-0301
2021-0401.22
2021-0501.78
2021-0601.67
2021-0702
2021-0802.14
2021-0901.25
2021-1002
2021-1101
2021-1201.86
2022-0101.33
2022-0201.17
2022-0312
2022-0401.91
2022-0501.71
2022-0605.25
2022-0701.71
2022-0806
2022-0902.38
2022-1003.33
2022-1102.67
2022-1204.25
2023-0102
2023-0202.5
2023-0302.71
2023-0402.14
2023-0503.5
2023-0605
2023-0701.71
2023-0803.5
2023-0903.4
2023-1022.67
2023-1101.83
2023-1206
2024-0106.67
2024-0234
2024-0306
2024-0402.75
2024-0504.33
2024-0603.67
2024-0705
2024-0802
2024-0932.5
2024-1001
2024-1195.8
2024-1232
2025-0102.5
2025-0201.67
2025-0303
2025-0403
2025-0504
2025-0602.5
2025-0703.5
2025-0802.33
2025-0901
2025-1032.5
2025-1121.5
2025-1202
2026-0102.33
2026-0202.5
2026-0322.5
2026-0405
2026-0502.25
2026-0603.33
This device (reports/month)Average device in IMD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Coopersurgical, Inc.

  • Warning Letter 2015-06-09 CooperSurgical, Inc.
  • Warning Letter 2015-06-09 CooperSurgical, Inc.
  • Warning Letter 2013-04-25 Lone Star Medical Products, Inc.
  • Warning Letter 2012-07-11 Leisegang Feinmechanick-Optik GmbH
  • VAI 2024-02-01 CooperSurgical, Inc. · 0 citations
  • NAI 2023-05-16 CooperSurgical, Inc. · 0 citations
  • NAI 2023-05-16 CooperSurgical, Inc. · 0 citations
  • VAI 2023-04-27 Lone Star Medical Products, Inc. · 5 citations
  • NAI 2022-12-15 Leisegang Feinmechanick-Optik GmbH · 0 citations
  • VAI 2021-07-15 CooperSurgical, Inc. · 4 citations
  • VAI 2021-07-15 CooperSurgical, Inc. · 4 citations
  • NAI 2019-08-01 CooperSurgical, Inc. · 2 citations
  • NAI 2018-05-02 Lone Star Medical Products, Inc. · 0 citations
  • NAI 2017-12-07 CooperSurgical, Inc. · 0 citations
  • NAI 2017-12-07 CooperSurgical, Inc. · 0 citations
  • NAI 2017-05-04 Lone Star Medical Products, Inc. · 0 citations
  • NAI 2016-03-31 CooperSurgical, Inc. · 0 citations
  • NAI 2016-03-31 CooperSurgical, Inc. · 0 citations
  • NAI 2015-12-10 Leisegang Feinmechanick-Optik GmbH · 0 citations
  • OAI 2014-12-17 CooperSurgical, Inc. · 8 citations
  • OAI 2014-12-17 CooperSurgical, Inc. · 8 citations
  • NAI 2014-12-01 CooperSurgical, Inc. · 0 citations
  • NAI 2014-12-01 CooperSurgical, Inc. · 0 citations
  • VAI 2014-09-23 Lone Star Medical Products, Inc. · 0 citations