Hill-Rom Recalls 94 Affinity Four Birthing Beds Due to Defect
Hill-Rom is voluntarily recalling 94 Affinity Four Birthing Beds (Model P3700) distributed in the US and abroad. The recall was initiated by the firm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences. The source does not report any injuries or deaths, and the specific defect is not detailed, placing it in the High severity category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hill-Rom, Inc. is voluntarily recalling 94 Affinity Four Birthing Beds, Model P3700. The recall was initiated by the firm on July 15, 2016, and was classified as Class II by the FDA. The beds were distributed in the United States to 16 states and internationally to Bulgaria, India, and the United Arab Emirates.
The source text does not specify the exact nature of the defect or the reason for the recall. The affected units are identified by specific lot numbers listed in the recall documentation. The recall status is currently terminated as of March 23, 2017.
Consumers and healthcare facilities should check their inventory for the specific lot numbers associated with this recall. If a unit is affected, it should be removed from service and the manufacturer contacted for instructions.
The recalled product
- Product
- Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping.…
- Manufacturer
- Hill-Rom, Inc.
- Category
- Medical Device — Hospital Bed
- Hazard
- Affected units
- 94
Distribution
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