Recall Z-1415-2022
Baxter Healthcare Corporation · initiated June 24, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
Codes / lots: 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…
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
The recalling firm issued a Medical Device Correction Letter dated 6/24/2022 via UPS on 6/24/2022. The letter described the problem, the potential risk, and the actions to be taken by the user. The actions were to inspect their product and check for any indication of error codes present. Identification of error codes were described depending on the configuration of the consignee's product. If the consignee detects an error code, they are to contact the Hillrom Technical Support to have the PRO+ Surface corrected. A list of affected serial numbers was attached to the letter as Appendix 1. Distributors were instructed to share the notification with their end users. A response form was attached to be completed and returned within 2 weeks to confirm they have reviewed and understand the attached letter and that distributors have shared the notification with their end users and will complete the field action
Details
- Recall number
- Z-1415-2022
- Initiated
- June 24, 2022
- Product code
- IOQ – Bed, Flotation Therapy, Powered
- Quantity
- 136 mattresses
- Distribution
- 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.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1411-2022 Class II | Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01…The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | 06/24/2022Open, Classified |
| Z-1412-2022 Class II | Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | 06/24/2022Open, Classified |
| Z-1413-2022 Class II | Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | 06/24/2022Open, Classified |
| Z-1414-2022 Class II | Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | 06/24/2022Open, Classified |
| Z-1416-2022 Class II | Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | 06/24/2022Open, Classified |
| Z-1417-2022 Class II | Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate… | 06/24/2022Open, Classified |