FDA Device recall Z-1411-2021
Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 17…
- FDA Device
- Class II
- ongoing
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class II recall of Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 17… by Covidien, citing investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connect….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1411-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-05 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, PR, SC, TX, UT, WA, WI, WV |
Product
Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094
Reason
Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.
Identifiers
| code_info | UDI-Device Identifier (GTIN/UPN): 10884523000887, 20884523000884 UDI-Device Identifier (GTIN/UPN): 10884523000900, 208…UDI-Device Identifier (GTIN/UPN): 10884523000887, 20884523000884 UDI-Device Identifier (GTIN/UPN): 10884523000900, 20884523000907 UDI-Device Identifier (GTIN/UPN): 10884523000917, 20884523000914 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1411-2021%22
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