FDAFDA · Food and drugs·Recall number Z-1237-2018
Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
Published April 4, 2018 · Recall initiated: December 13, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product reportedly shutting down during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LLC
- Distributor
- Worldwide Distribution: US (Nationwide).
- Lot
- SIGPHANDLE-UDI #10884521543782 Serial# C17AAA0001 C17AAA0002 C17AAA0003 C17AAA0004 C17AAA0005 C17AAA0006 C17AAA0007 C17AAA0008 C17AAA0009 C17AAA0010 C17AAA0011 C17AAA0012 C17AAA0013 C17AAA0014 C17AAA0015 C17AAA0017 C17AAA0018 C17AAA0019 C17AAA0020 C17AAA0021 C17AAA0022 C17AAA0023 C17AAA0024 C17AAA0026 C17AAA0027 C17AAA0028 C17AAA0029 C17AAA0030 C17AAA0031 C17AAA0032 C17AAA0033 C17AAA0034 C17AAA0035 C17AAA0036 C17AAA0037 C17AAA0038 C17AAA0039 C17AAA0040 C17AAA0042 C17AAA0043 C17AAA0044 C17AAA0045 C17AAA0046 C17AAA0047 C17AAA0048 C17AAA0049 C17AAA0050 C17AAA0051 C17AAA0052 C17AAA0053 C17AAA0054 C17AAA0055 C17AAA0056 C17AAA0057 C17AAA0058 C17AAA0059 C17AAB0002 C17AAB0003 C17AAB0004 C17AAB0005 C17AAB0006 C17AAB0007 C17AAB0008 C17AAB0009 C17AAB0010 C17AAB0011 C17AAB0012 C17AAB0013 C17AAB0014 C17AAB0015 C17AAB0016 C17AAB0017 C17AAB0018 C17AAB0019 C17AAB0020 C17AAB0021 C17AAB0022 C17AAB0023 C17AAB0024 C17AAB0025 C17AAB0026 C17AAB0027 C17AAB0028 C17AAB0029 C17AAB0030 C17AAB0031 C17AAB0032 C17AAB0033 C17AAB0034 C17AAB0035 C17AAB0036 C17AAB0037 C17AAB0038 C17AAB0039 C17AAB0040 C17AAB0041 C17AAB0042 C17AAB0043 C17AAB0044 C17AAB0045 C17AAB0046 C17AAB0047 C17AAB0048 C17AAB0049 C17AAB0050 C17AAB0051 C17AAB0052 C17AAB0053 C17AAB0054 C17AAB0055 C17AAB0056 C17AAB0057 C17AAB0058 C17AAB0059 C17AAB0060 C17AAB0061 C17AAB0062 C17AAB0063 C17AAB0064 C17AAB0065 C17AAB0066 C17AAB0069 C17AAB0070 C17AAB0072 C17AAB0073 C17AAB0074 C17AAB0075 C17AAB0076 C17AAB0077 C17AAB0078 C17AAB0079 C17AAB0080 C17AAB0081 C17AAB0082 C17AAB0083 C17AAB0084 C17AAB0085 C17AAB0086 C17AAB0087 C17AAB0088 C17AAB0089 C17AAB0090 C17AAB0091 C17AAB0092 C17AAB0093 C17AAB0094 C17AAB0095 C17AAB0096 C17AAB0097 C17AAB0098 C17AAB0099 C17AAB0101 C17AAB0102 C17AAB0103 C17AAB0104 C17AAB0105 C17AAB0107 C17AAB0108 C17AAB0109 C17AAB0110 C17AAB0111 C17AAB0112 C17AAB0113 C17AAB0114 C17AAB0115 C17AAB0116 C17AAB0118 C17AAB0120 C17AAB0121 C17AAB0122 C17AAB0123 C17AAB0124 C17AAB0125 C17AAB0126 C17AAB0127 C17AAB0128 C17AAB0129 C17AAB0130 C17AAB0131 C17AAB0132 C17AAB0133 C17AAB0134 C17AAB0135 C17AAB0136 C17AAB0137 C17AAB0138 C17AAB0139 C17AAB0140 C17AAB0141 C17AAB0142 C17AAB0143 C17AAB0145 C17AAB0146 C17AAB0147 C17AAB0148 C17AAB0149 C17AAB0150 C17AAB0151 C17AAB0152 C17AAB0153 C17AAB0155 C17AAB0156 C17AAB0157 C17AAB0158 C17AAB0159 C17AAB0160 C17AAB0161 C17AAB0162 C17AAB0163 C17AAB0164 C17AAB0165 C17AAB0166 C17AAB0167 C17AAB0168 C17AAB0169 C17AAB0170 C17AAB0171 C17AAB0172 C17AAB0173 C17AAB0174 C17AAB0175 C17AAB0176 C17AAB0177 C17AAB0178 C17AAB0179 C17AAB0180 C17AAB0181 C17AAB0182 C17AAB0183 C17AAB0184 C17AAB0185 C17AAB0186 C17AAB0187 C17AAB0188 C17AAB0189 C17AAB0190 C17AAB0191 C17AAB0192 C17AAB0193 C17AAB0194 C17AAB0195 C17AAB0196 C17AAB0197 C17AAB0198 C17AAB0199 C17AAB0200 C17AAB0201 C17AAB0202 C17AAB0203 C17AAB0204 C17AAB0205 C17AAB0206 C17AAB0207 C17AAB0208 C17AAB0209 C17AAB0210 C17AAB0211 C17AAB0212 C17AAB0213 C17AAB0214 C17AAB0215 C17AAB0216 C17AAB0217 C17AAB0218 C17AAB0219 C17AAB0220 C17AAB0221 C17AAB0222 C17AAB0223 C17AAB0224 C17AAB0225 C17AAB0226 C17AAB0227 C17AAB0228 C17AAB0230 C17AAB0231 C17AAB0232 C17AAC0001 C17AAC0002 C17AAC0003 C17AAC0004 C17AAC0005 C17AAC0006 C17AAC0007 C17AAC0008 C17AAC0009 C17AAC0010 C17AAC0011 C17AAC0012 C17AAC0013 C17AAC0014 C17AAC0015 C17AAC0016 C17AAC0017 C17AAC0018 C17AAC0019 C17AAC0020 C17AAC0022 C17AAC0023 C17AAC0024 C17AAC0025 C17AAC0026 C17AAC0027 C17AAC0028 C17AAC0029 C17AAC0030 C17AAC0032 C17AAC0033 C17AAC0034 C17AAC0035 C17AAC0036 C17AAC0037 C17AAC0039 C17AAC0040 C17AAC0041 C17AAC0042 C17AAC0043 C17AAC0044 C17AAC0045 C17AAC0046 C17AAC0047 C17AAC0048 C17AAC0049 C17AAC0050 C17AAC0051 C17AAC0052 C17AAC0053 C17AAC0054 C17AAC0055 C17AAC0056
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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