FDA Recall Terminated

(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.

Recall: Z-0833-2022 · Initiated February 23, 2022

Recall

Recall Number: Z-0833-2022
Event Number: 89561
Firm: Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845
FEI Number: 3008002452
Product Code: HET
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: February 23, 2022
Terminated: May 2, 2023

Description

Reason

The finished device package did not contain the IFU.

Action

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.

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