FDA Device recall Z-0833-2022
(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910
- FDA Device
- Class II
- terminated
- Published 2022-04-06
On 2022-04-06 the FDA classified a Class II recall of (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910 by Carefusion 2200, citing the finished device package did not contain the IFU.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0833-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-23 |
| Published | 2022-04-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carefusion 2200 |
| Distribution | US |
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.
Identifiers
| code_info | (a) Catalog #88-5910 - Lot numbers C17XRD and K17XRD, UDI 10885403153341; (b) Catalog #88-5920 - Lot numbers XRDX02, XR…(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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0833-2022%22
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