FDA Device recall Z-3278-2018
Retractor System Elastic Stays (Part 3314-lG
- FDA Device
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of Retractor System Elastic Stays (Part 3314-lG by Coopersurgical, citing there is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3278-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-04 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.
Reason
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Identifiers
| code_info | Lots 244660, 245964, 250426, 251395 , 244667, 244883, 244884, 245603, 245973, 246138, & 248871 |
|---|
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-3278-2018%22
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