FDA Recall Terminated

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.

Recall: Z-2750-2016 · Initiated July 15, 2016

Recall

Recall Number
Z-2750-2016
Event Number
74760
Firm
Hill-Rom, Inc.
FEI Number
1824206
Product Code
KNC
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
July 15, 2016
Posted
September 8, 2016
Terminated
March 23, 2017
Address
1069 State Road 46 E, Batesville, IN, 47006-7520

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.

Action

Hill-Rom Inc. initiated a voluntary recall of the Affinity Four Birthing Beds on July 15, 2016, with letters to customers mailed certified via FedEx. Customers were asked to do the following: During use, if you encounter a situation where the CPR mechanism fails to activate, the head of the bed can still be lowered, electrically, using the siderail articulation controls. A Hill-Rom representative will be contacting each facility to make arrangements for replacing the affected head drive. Please pass this notice on to all those who need to be aware within your organization and/or to any organization where the affected devices have been transferred. If you have any questions concerning this correction, please contact Hill-Rom Technical Support at 800-445-3720.

Distribution

US Distribution to the states of : CA, FL, IN, KS, LA, MI, MO, NC, NY, OK, OR, PA, TN, TX, WA, WY Foreign:BULGARIA, INDIA, UNITED ARAB EMIRATES

Quantity

94 beds