Recall Z-2750-2016— Hill-Rom, Inc.

Class II · Terminated

Class II FDA medical device recall by Hill-Rom, Inc., initiated 2016-07-15, terminated 2017-03-23. It names one FDA 510(k) clearance: K915779. 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. These are shipped in standard freight containers. There is no secondary packaging..

Recalling firm
Hill-Rom, Inc.
Classification
Class II
Status
Terminated
Initiated
2016-07-15
Terminated
2017-03-23
Firm location
Batesville, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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. These are shipped in standard freight containers. There is no secondary packaging.

Data sourced from openFDA. This site is unofficial and independent of the FDA.