Z-1415-2022 Class II Ongoing
FDA device recall Z-1415-2022 was initiated by Baxter Healthcare Corporation on Jun 24, 2022 and is designated Class II. Reason for recall: The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an… The recall status is ongoing. Affected quantity: 136 mattresses.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 27, 2022
- Initiation Date
- Jun 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136 mattresses
Product Description
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
Reason for Recall
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NM, NM, NY, OH, OK, RI, SD, TN, TX, VT, and WI. There was government distribution but no military distribution. The country of Canada.
Code Information
UDI 00887761977945; Serial numbers: W238BP4338, W238BP4339, W238BP4340, W238BP4341, W238BP4342, W238BP4344, W238BP4345, W238BP4347, W238BP4348, W355BP6966, W355BP6978, W355BP6979, W355BP6980, W355BP6981, W355BP6982, W355BP6986, W355BP6987, W355BP6988, W355BP6989, W355BP6990, W357BP6994, W357BP6996, W357BP6997, W357BP6998, W357BP7006, W357BP7007, W357BP7009, W357BP7012, W357BP7015, W357BP7016, W357BP7017, W357BP7018, W357BP7019, W357BP7021, W357BP7022, W357BP7023, W357BP7024, W357BP7025, W357BP7026, W357BP7027, W354BP6891, W354BP6892, W354BP6897, W354BP6898, W354BP6899, X003BP7030, X003BP7031, X003BP7036, X003BP7037, X003BP7039, X003BP7040, X003BP7041, X003BP7047, X003BP7049, X003BP7050, X005BP7090, X005BP7091, X005BP7096, X005BP7097, X005BP7098, W354BP6921, W354BP6922, W354BP6923, W354BP6931, W354BP6932, X005BP7087, X005BP7088, X005BP7089, X005BP7094, X005BP7095, W354BP6910, W354BP6911, W354BP6918, W354BP6936, W354BP6939, W355BP6945, X003BP7055, X003BP7057, X005BP7059, X005BP7060, X005BP7061, X005BP7064, X005BP7065, X005BP7066, X005BP7067, X005BP7083, X005BP7086, X005BP7093, X005BP7104, X005BP7106, X005BP7110, X005BP7111, W354BP6908, W354BP6909, W354BP6916, W354BP6917, W354BP6919, W354BP6920, W354BP6924, W354BP6925, W354BP6926, W354BP6927, W354BP6928, W354BP6929, W354BP6933, W354BP6934, W354BP6935, W354BP6940, W354BP6941, W354BP6942, W355BP6944, W355BP6946, W355BP6948, W355BP6949, W355BP6950, W355BP6951, W355BP6952, W355BP6953, W355BP6955, W355BP6956, W355BP6957, W355BP6958, W355BP6959, W355BP6960, W355BP6961, W355BP6976, W355BP6977, W355BP6983, W355BP6984, W355BP6985, X005BP7084, X005BP7085, X005BP7108, X005BP7109, W354BP6906, and W354BP6930.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1415-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026