Reported Aug 1, 2012 · Terminated
Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds…
Hill-Rom, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hill-Rom, Inc. · 1069 State Route 46 East · Batesville, IN · 47006-7520
Is this the product you have?
- Affinity
- Four Birthing Bed P3700 Product UsageThe 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
- Lot codes and dates
- Affinity Four Birthing Beds (P3700) manufactured with Serial Numbers H331AA4785 thru N081AA7966
- Amount recalled
- 12,726 devices
Where it was sold
- Nationwide
- PR
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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