CanadaMedline convenience kits containing select 10 mL polycarbonate colored syringes (Medline Industries, LP) are affected; affected kits include PCI Pack (model DYNJ41941D; multiple lot/serial numbers), Ensemble Gyneco Scopie (DYNJ53744B; lot 24ABS765), Ensemble Hemorroides (DYNJ56311A; lot 24ABR871), Lavh GRH LF (DYNJ41792G; lot 24ABT556) and Gyne Laparotomy Pack (DYNJ49593A; lot 21FBM893). They were recalled after unapproved design changes to the syringes were identified outside the FDA 510(k) clearance; customers must discard the affected syringe products (remaining items in the kit may be used) and contact the manufacturer for more information.
What's being recalled
Companies: Medline Industries, LP, Three Lakes Drive, Northfield, Illinois, United States, 60093.
How to identify it
Affected products: PCI Pack; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: DYNJ41941D
Affected products: Ensemble Gyneco Scopie; Lot or serial number: 24ABS765; Model or catalogue number: DYNJ53744B
Affected products: Ensemble Hemorroides; Lot or serial number: 24ABR871; Model or catalogue number: DYNJ56311A
Affected products: Lavh GRH LF; Lot or serial number: 24ABT556; Model or catalogue number: DYNJ41792G
Affected products: Gyne Laparotomy Pack; Lot or serial number: 21FBM893; Model or catalogue number: DYNJ49593A
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States