Covidien LLC: 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" Te

Is my product affected?

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 thoraci

• UPC 10884521543782

Check against the official notice below — it lists the full affected range.

What happened

Covidien LLC is recalling approximately 2,121 Signia Power Handle units (model numbers SIGPHANDLE, SIGNVAL1, and SIGVAL20 kits) used with Endo GIA single-use reloads. The devices have been reported to shut down during use. The affected units were distributed nationwide in the United States and worldwide, and can be identified by their UDI number 10884521543782 and specific serial numbers beginning with C17AAA or C17AAB.

The recall record does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Product reportedly shutting down during use.

Details from the source

Reason for recall: Product reportedly shutting down during use. Distribution: Worldwide Distribution: US (Nationwide). Quantity: 2121 Lot/code info: 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 C17AAB008

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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