Snowden-Pencer recallZ-0833-2022 · Carefusion 2200 Inc · initiated Feb 23, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carefusion 2200 Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The finished device package did not contain the IFU.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The recalling firm issued letters dated 2/23/2022 on the same date via email and FedEx 2 day delivery. The letter described the issue and the health hazards involved and requested the consignee to take the following actions: (1) Check all inventory locations for the affected catalog/lot numbers; (2) The IFU is provided with the letter and the consignee is requested to maintain it in the appropriate location as determined by their facility. If more than one IFU is required, the consignee is to contact BD; (3) Share the recall notice with any users of the product within their facility to ensure they are aware of the recall notification. If the product has been transferred or further distributed outside of their facility, they are requested to provide a copy of the letter to those locations; (4) Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the recall notification regardless of whether they have the affected product; and (5) Report any adverse health consequences experienced with the use of the product to BD.
Recall details
- Recall number
- Z-0833-2022
- Status
- Terminated
- Initiated by the company
- Feb 23, 2022
- Recalling firm
- Carefusion 2200 Inc
- Quantity
- 152 units
- Product code
- HET
- FDA submissions
- K982276
- 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.
Product description
(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 #88-9808; and (d) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809.
Code information (models, lots, serial numbers)
(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.
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Snowden-Pencer 88-5910Steris Corporation · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)1 recall0 reports
- Snowden-Pencer 88-5920Steris Corporation · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)1 recall0 reports
- Snowden-Pencer 88-9808Steris Corporation · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)1 recall0 reports
- Snowden-Pencer 88-9809Steris Corporation · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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