Z-0833-2022Class II

(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog...

Name: Z-0833-2022 (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog...
Creator: Carefusion 2200 Inc
Published: 2022-02-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-02-23 / Terminated / root cause: manufacturing process

FDA source

Carefusion 2200 Inc began a recall of (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics... on 2022-02-23. FDA classified it as Class II and gives the reason as "The finished device package did not contain the IFU". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0833-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-23
Posted: 2022-03-30
Terminated: 2023-05-02
Recalling firm: Medtronic, Inc.
Product: (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.
Product code: HET Laparoscope, Gynecologic (And Accessories)
Reason for recall: The finished device package did not contain the IFU.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 152 units
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 codes and lots: (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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0833-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0833-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-06	2022-03-30

Product code HET

K982276Class IIBaho Autoclavable LaparoscopeMicroptix Int'L, LLC / cleared 1999-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)