HMPClass I

Pad, Eye

General, Plastic Surgery · 21 CFR 878.4440

MDR events10All time

Recalls4All time

Registered firms178Currently listed

510(k) clearances17All time

Recent MDR events

10 adverse event reports on file

Event type breakdown

Malfunction7

Unspecified1

Injury1

Other1

Most-reported manufacturers

Covidien8 Allegiance-surgical Group1 Johnson & Johnson Medical, Inc.1

Recalls

4 recall events for this product code

MEDLINE INDUSTRIES, LP - Northfield
Open, ClassifiedFeb 25, 2024
Centurion Kits, trays, and packs labeled as follows:
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Z-1131-2024 · View FDA record ↗
Covidien LLC
TerminatedMar 27, 2017
Covidien Curity Eye Pad
Product sterility is compromised due to breach of sterile barrier
Z-1739-2017 · View FDA record ↗
Covidien LLC
TerminatedMar 27, 2017
Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile
Product sterility is compromised due to breach of sterile barrier
Z-1740-2017 · View FDA record ↗
Covidien LLC
TerminatedMar 27, 2017
Covidien Curity Eye Pad
Product sterility is compromised due to breach of sterile barrier
Z-1741-2017 · View FDA record ↗

Registered firms

178 firms currently registered for this product code

510(k) clearances

17 clearances for this product code