Health product recall

Ultracell Wick With 80cc Collection Bag

Dernière mise à jour

Summary

Produit
Ultracell Wick With 80cc Collection Bag
Problème
Medical devices - Sterility Issue
Ce qu’il faut faire

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Ultracell Wick With 80cc Collection Bag

21L3403
21M3820

40430

Problème

BVI has received two complaints from customers that identified an end of the sterile pouch of model #40430 PVA Ultracell Medical Sponges was not sealed. Two lots (21m3820 and 21l3403) have been identified as affected by this failure mode. BVI has determined through testing that the packaging sterile barrier has been compromised. This seal provides sterility for the product within the packaging. Open seals can lead to a loss of device sterility, which in turn may lead to infection.

Recall start date: February 7, 2023

Additional information

Details
Original published date: 2023-03-29
Type d’avis ou de rappel
Health product recall
Catégorie
Health product - Medical device - Ophthalmology
Entreprises

Beaver-Visitec International, Inc

500 Totten Pond Rd. - 10 Citypoint, Waltham, Massachusetts, United States, 02451

Published by
Health Canada
Audience
Healthcare
Classe de rappel
Type II
Identification number
RA-73403