Information Bulletin 93-1
Recall Of Ultra Therm Disposable Fluid Warmer
The Department of Health and Human Services, Health Care Financing Administration Region V office has requested that we distribute information regarding the recall of the Ultra Therm Disposable Fluid Warmer, Model 3703-1, which is made by the PMT Corporation of Chanhassen, Minnesota. Following is a copy of the FDA bulletin regarding the recall of this device.
FOOD AND DRUG ADMINISTRATION
Recall and Notification Branch, HFZ-321
Office of Compliance and Surveillance, CDRH
Recall Number, Health Hazard Evaluation and Recall Strategy Ultra Therm Disposable Fluid Warmer,
Model 3703-1; PMT Corporation, Chanhassen, Minnesota.
MIN-DO/Dirk J. Mouw/HFR-MW395
We are assigning Recall No. Z-123-3 to the subject device and are classifying the firm's action as a voluntary recall. We consider the device to be adulterated and misbranded. The device lacked adequate warning and directions for use in that the user was not warned that:
- If blood or blood products are being introduced at extremely low flow rates, the potential exists that damage may occur to the blood or blood products which could limit their effectiveness and/or cause serious injury or death;
- If flow of fluid through the warmer is interrupted, the tubing must be removed from the heating unit immediately;
- The physician should provide filters as well as coagulation and occlusion indicators with the device; and
- Extreme caution should be used when using the device on pediatric patients.
Only one set of instructions is provided in a container of twelve or more units. There are no instructions for use on the device itself. There is no 510(k) submission for the Model 3703-1. The device presents an unknown risk of serious adverse health consequences and possible death.
- Class: II
- Depth: Medical Facilities
- Firm Effectiveness Check: Level A. Firm is to conduct effectiveness checks on all final users.
- FDA Audit Check: Level B. Agency is to conduct audit checks on 20% of all final domestic users.
- Publicity: FDA Enforcement Report only.
CDRH suggests you telephone the firm immediately to inform it of the recall number and strategy and that it will be published in the FDA Enforcement Report. The firm should also be informed that CDRH expects this recall to be completed within three months from the data of initiation of the recall. The firm is to report any failures to meet this time immediately to the district R&E Coordinator.
John H. Samalik
R/D: Final: LEBrown:11/30/92