FDA Device recall Z-1222-2017
Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
- FDA Device
- Class II
- terminated
- Published 2017-02-22
On 2017-02-22 the FDA classified a Class II recall of Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010 by Atrium Medical, citing labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1222-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-20 |
| Published | 2017-02-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Atrium Medical |
| Distribution | US |
Product
Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
Reason
Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)
Identifiers
| code_info | All Lot Numbers With Expiration Date Prior To December 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1222-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.