Boston Scientific Corporation: Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina duri

Is my product affected?

Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210

• UPC 08714729848097

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

What happened

Boston Scientific Corporation has recalled 4,549 units of the Colpassist Vaginal Positioning Device worldwide due to a potential sterile barrier breach. The devices, which are used in gynecological surgery to position and manipulate the vagina, may have pinholes on the edge of the pouch that could render them non-sterile and potentially result in post-operative infections. The recall affects unexpired lots distributed across the United States and numerous countries including Canada, Mexico, Australia, and multiple European nations.

The affected lots include all unexpired units designated C003699 through C004221. The source does not specify a remedy for affected consumers.

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

Hazard

Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection

Details from the source

Reason for recall: Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection Distribution: Worldwide distribution - US Nationwide distribution and the countries of Algeria, Brazil, Colombia, Estonia, Germany, Hong Kong, Australia, Canada, Costa Rica, Finland, Great Britain, Italy, Austria, Chile, Czech Republic, France, Greece, Jordan, Belgium, Lebanon, Mauritius, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Serbia, Slovakia, Sloveni Quantity: 4,549 WW Lot/code info: All unexpired lots: C003699 C003715 C003735 C003750 C003775 C003804 C003813 C003842 C003853 C003887 C003905 C003936 C003950 C003960 C003966 C003986 C003997 C004028 C004041 C004078 C004091 C004107 C004117 C004128 C004136 C004160 C004186 C004206 C004221 GTIN 08714729848097

Source

Official record: FDA (Device enforcement) ↗

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

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All FDA (Device enforcement) recalls