Hill-Rom Affinity Three Birthing Bed, Model P3700A.
FDA device recall Z-0583-2008 · posted 2008-02-22 · Terminated
Recall details
- Recalling firm
- Hill-Rom, Inc.
- Reason for recall
- Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated.
- Action taken
- Consignees were notified of the problem via an Urgent Medical Device Correction letter dated 11/21/07. Users were informed that they would be receiving a free upgrade kit for all of their Affinity Birthing Beds. The Kit includes two plugs per bed, an insertion tool, and full written instructions. An instruction video is available at www.Hill-Rom.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KNC
- Quantity affected
- 32,379 for all model numbers
- Distribution
- Worldwide Distribution-- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus,
- Date initiated
- 2007-11-21
- Date posted
- 2008-02-22
- Date terminated
- 2009-09-22
- Location
- Batesville, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AFFINITY BED MODEL 3600 SERIES (K915779) | Hill-Rom, Inc. | 1993-02-24 |