Recall Monitor
Health Products

Medline Convenience Kits Containing Select Polycarbonate Colored Syringes

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
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
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
PCI PackMore than 10 numbers, contact manufacturer.DYNJ41941D
Ensemble Gyneco Scopie24ABS765DYNJ53744B
Ensemble Hemorroides24ABR871DYNJ56311A
Lavh GRH LF24ABT556DYNJ41792G
Gyne Laparotomy Pack21FBM893DYNJ49593A

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.

Get told about the next health product recall.
Get health product recall alerts

CA$3.99/mo · cancel anytime