Recall Z-2268-2010
Hill-Rom, Inc. · initiated April 13, 2009
Product
Hill-Rom 1000 bed model P1160.
Codes / lots: K029AP6787, K029AP6788, K029AP6790, J317AP5267, J206AP2503, J206AP2506, J206AP2511, J206AP2513, J213AP2581, J220AP2773, J220AP2775, J220AP2777, J220AP2778, J224AP2904, J224AP2906, J224AP2907, J224AP2908, J220AP2770, J224AP2909, J224AP2916, J227AP3052, J227AP3053, K027AP6733, K027AP6735, K027AP6736, K027AP6738, J220AP2772, J220AP2774, J224AP2905, J274AP4108, J274AP4113, J274AP4114, J274AP4134, J274AP4135, J274AP4136, J274AP4102, J350AP5889, J350AP5890, J350AP5891, J350AP5892, J350AP5893, J350AP5894, J350AP5895, J350AP5896, J350AP5897, J350AP5899, J350AP5900, J350AP5901, J350AP5902, J350AP5903, J350AP5904, J350AP5905, J350AP5906, J350AP5907, J350AP5908, J350AP5909, J350AP5998, J352AP5988, J352AP5989, J352AP5990, J352AP5991, J352AP5992, J352AP5993, J352AP5994, J352AP5995, J352AP5996, J352AP5997, J352AP5998, J352AP5999, J352AP6000, J352AP6001, J352AP6002, J352AP6003, J352AP6004, J352AP6005, J352AP6006, J352AP6007, J352AP6008, J352AP6009, J352AP6010, J352AP6011, J352AP6012, K020AP6555, K020AP6556, K020AP6557, K020AP6558, K020AP6559, K020AP6560, J354AP6044, J354AP6045, J354AP6046, J354AP6047, J354AP6048, J354AP6049, J354AP6050, J354AP6051, J354AP6052, J354AP6053, J354AP6054…
Reason for recall
Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed.
FDA-determined cause: Device Design
Action taken
Hill-Rom sent a customer notification letter dated 4/9/2009. A second notice was sent to all customers on 7/9/2009. The letter included instructions and a Customer Response Form, along with the required parts. Customers were instructed to do the correction on their affected beds and return the completed customer response form within 45 days.
Details
- Recall number
- Z-2268-2010
- Initiated
- April 13, 2009
- Posted by FDA
- August 24, 2010
- Terminated
- June 6, 2011
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Quantity
- 39,971 both products
- Distribution
- Worldwide distribution: USA, Afghanistan, Algeria, American Samoa, Argentina, Australia, Bermuda, Brazil, Canada, Chili, China, Colombia, Costa Rica, Cuba, Ecuador, Egypt, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Kyrgyzstan, Lebanon, Libya, Malaysia, Mexico, Oman, Panama, Paraguay, Philippines, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Syria, Taiwan…
- Recalling firm
- Hill-Rom, Inc., Batesville, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2267-2010 | Hill-Rom Care Assist Bed, Model P1170.Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the… | 04/13/2009Terminated |