Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2268-2010

Hill-Rom 1000 bed model P1160

Hill-Rom Inc. / initiated 2009-04-13 / Terminated / root cause: design

Hill-Rom, Inc. began a recall of Hill-Rom 1000 bed model P1160 on . The reason FDA records is "Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2268-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Hill-Rom 1000 bed model P1160.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
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.
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
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, Thailand, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.
Product codes and 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, J354AP6056, J354AP6057, J354AP6058, J354AP6059, J354AP6042, J354AP6043, J274AP4103, J274AP4105, J274AP4106, J274AP4107, J274AP4109, J274AP4110, J274AP4111, J274AP4115, J274AP4117, J274AP4118, J274AP4120, J274AP4125, J274AP4127, J274AP4129, J274AP4132, J274AP4137, J274AP4138, J282AP4359, J282AP4365, J282AP4366, J324AP5383, J324AP5384, J324AP5385, J324AP5386, K027AP6720, K027AP6723, K027AP6726, K027AP6727, K027AP6728, K027AP6729, K027AP6730, K027AP6731, K027AP6732, K027AP6734, K027AP6737, K027AP6739, K027AP6740, K027AP6741, K027AP6742, K028AP6773, K028AP6774, K038AP6999, K038AP7000, K038AP7001, K038AP7002, J274AP4099, J274AP4100, J274AP4112, J274AP4116, J274AP4119, J274AP4122, J274AP4126, J274AP4131, J206AP2509, J213AP2580, J220AP2764, J220AP2767, J227AP3035, J227AP3036, J227AP3037, J227AP3039, J227AP3040, J227AP3041, J227AP3042, J227AP3043, J227AP3044, J227AP3045, J227AP3046, J227AP3047, J227AP3048, J227AP3049, J227AP3051, J206AP2508, J206AP2512, J213AP2578, J213AP2579, J206AP2505, J220AP2761, J220AP2762, J220AP2763, J220AP2765, J220AP2766, J220AP2768, J220AP2769, J227AP3038, J274AP4097, J274AP4098, J274AP4104, J274AP4128, J274AP4130, J274AP4133, K006AP6220, K006AP6221, J309AP4986, J309AP4987, J309AP4988, J309AP4989, J309AP4990, J309AP4991, J143AP0940, J143AP0941, J143AP0937, J143AP0944, J143AP0943, J220AP2788, J220AP2789, J274AP4121, J206AP2504, J206AP2507, J206AP2510, J206AP2514, J240AP3514, J317AP5268, J317AP5269, J143AP0945, J143AP0946, J220AP2771, J220AP2776, J220AP2779, J220AP2780, J220AP2781, J220AP2790, J220AP2791, J220AP2792, J227AP3054, J227AP3055, J227AP3056, J239AP3425, J239AP3426, J239AP3428, J239AP3429, J239AP3430, J239AP3431, J239AP3432, J143AP0939, J354AP6055 and J303AP4873.