Recall Z-0833-2022— Carefusion 2200 Inc

Name: FDA recall Z-0833-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-23

Class II · Terminated

Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2022-02-23, terminated 2023-05-02. It names one FDA 510(k) clearance: K982276. 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.. Reason: The finished device package did not contain the IFU..

Recalling firm: Carefusion 2200 Inc
Classification: Class II
Status: Terminated
Initiated: 2022-02-23
Terminated: 2023-05-02
Firm location: Vernon Hills, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K982276 — BAHO AUTOCLAVABLE LAPAROSCOPEMicroptix Int'L, LLC·cleared 1999-02-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

The finished device package did not contain the IFU.

Data sourced from openFDA. This site is unofficial and independent of the FDA.