(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #8
Check against the official notice below — it lists the full affected range.
CareFusion 2200 Inc. is recalling 152 units of CareFusion Snowden-Pencer Plastics endoscopes across multiple catalog numbers (88-5910, 88-5920, 88-9808, and 88-9809) distributed nationwide in the United States, as well as in Taiwan and Australia. The recall was initiated because the finished device packages did not contain the Instructions for Use (IFU).
The affected products are identified by specific lot numbers associated with each catalog number and unique device identifiers (UDIs). The record does not specify a remedy or recommended action for consumers who may have received these products.
Written by software from the official notice below. Not reviewed by a lawyer.
The finished device package did not contain the IFU.
Reason for recall: The finished device package did not contain the IFU. Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, IN, LA, MA, MI, MN, MS, MT, NC, NY, OH, OK, PA, TN, TX, VA, and WI. The countries of Taiwan and Australia. Quantity: 152 units Lot/code info: (a) Catalog #88-5910 - Lot numbers C17XRD and K17XRD, UDI 10885403153341; (b) Catalog #88-5920 - Lot numbers XRDX02, XRDZ07, K17XRD, C18XRD, G18XRD, C19XRD, D20XRD, G20XRD, J19XRD, K19XRD; UDI 10885403153358; (c) Catalog #88-9808 - Lot numbers XRDV09, G20XRD, 864909; UDI 10885403155314; and (d) Catalog #88-9809 - Lot numbers XRDV09, XRDV10, XRDX06, B18XRD, D18XRD, G20XRD; UDI 10885403155321.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.