Medline Convenience Kits Containing Select Polycarbonate Colored Syringes
Brand(s)
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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