Oto Med Inc: Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery

Is my product affected?

Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

• UPC 00850000126046

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

What happened

Oto Med Inc is recalling 13,335 Grace Medical REF S-2500 Sheehy Bone Dust Collector devices, which are stainless steel filters intended to be inserted into suction tubes during early-stage ear surgery. The recall was initiated because holes were discovered in the sterile Tyvek pouches during internal age testing of the devices.

The affected devices were distributed worldwide, including throughout the United States and in Argentina, Brazil, Colombia, Chile, Hong Kong, South Africa, United Arab Emirates, Taiwan, Canada, and India. The specific lot numbers involved are 019120G(2), 029119G(2), 039118G(2), 049119G(2), 0712119G(2), 0812118G(2), 0912118G(2), 1012119G(2), 1212118G(2), and 200401 (UDI Code 00850000126046). The source document 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

During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.

Details from the source

Reason for recall: During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices. Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of MN, IL, PA, WI, GA, SD, FL, AR, MA, AZ, TX, MO, NC, CA, UT, DE, OR, IN, CO, AL, OH, NY, WA, DC, TN, NH, VT, VA, SC, MI, WI, MS, IA, NJ, MD, KS, CT, LA, ME, KY, HI, TN, RI, NV, ID and the countries of Argentina, Brazil, Colombia, Chile, Hong Kong, South Africa, United Arab Emirates, Taiwan, Canada, India. Quantity: 13,335 devices Lot/code info: UDI Code: 00850000126046 Lot Numbers: 019120G(2) 029119G(2) 039118G(2) 049119G(2) 0712119G(2) 0812118G(2) 0912118G(2) 1012119G(2) 1212118G(2) 200401

Source

Official record: FDA (Device enforcement) ↗

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

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