Health product recall

Medline Convenience Kits Containing Select Polycarbonate Colored Syringes

Last updated

Summary

Product
Medline Convenience Kits Containing Select Polycarbonate Colored Syringes
Issue
Medical devices - Unauthorised device
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

PCI Pack

More than 10 numbers, contact manufacturer.

DYNJ41941D

Ensemble Gyneco Scopie

24ABS765

DYNJ53744B

Ensemble Hemorroides

24ABR871

DYNJ56311A

Lavh GRH LF

24ABT556

DYNJ41792G

Gyne Laparotomy Pack

21FBM893

DYNJ49593A

Issue

Specific item(s) and lot(s) of Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes are recalled, after identifying unapproved design changes to the products outside of the 510(k) cleared by FDA. Customers must discard the affected products, but all remaining products inside of the kit may be used.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Medline Industries, LP

Three Lakes Drive, Northfield, Illinois, United States, 60093

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82000

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