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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Product Detail

Product Description Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. They are not intended for use as general hospital beds.
Recall Number Z-2082-2012
Classification Class II
Code Info Affinity Four Birthing Beds (P3700) manufactured with Serial Numbers H331AA4785 thru N081AA7966
Product Distributed Qty 12,726 devices
Reason For Recall During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or during the birthing process may still create distractions and delays, resulting in patient or caregiver falls, or contribute to a deviation in a procedure, (e.g. IV insertion, epidural placement, episiotomy incision, vacuum extraction, forceps delivery, suprapubic pressure). In an effort to further improve the braking system of the Affinity Four Birthing Bed, Hill-Rom developed an enhanced brake detent assembly.

Event Detail

Event Id 62453
Product Type Devices
Status Ongoing
Recalling Firm Hill-Rom, Inc.
City Batesville
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US Nationwide and countries including: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Turks and Caicos Islands, United Arab Emirates, United Kingdom, United States, US Virgin Islands, Venezuela and Vietnam
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