Affinity Four Birthing Bed P3700 Product Usage: The recall
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…
Why was Affinity Four Birthing Bed P3700 Product Usage: The recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Affinity Four Birthing Beds (P3700) manufactured with Serial Numbers H331AA4785 thru N081AA7966
- Product
- 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…
- Recalling firm
- Hill-Rom, Inc.
- Quantity
- 12,726 devices
- Distribution
- 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
- Recall date
- August 1, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)