CanadaTamper Evident Additive Port Cap (model/catalogue number 21-01; lot/serial numbers 58203, 58590, 57325, 56586) from International Medical Industries, Inc. is affected and can be identified by the product name and those identifiers. IMI initiated the recall because the corrugated shipper box contains incorrect compatibility information; the device label and IFU are correct, users are advised not to discard or return the device, verify compatibility using the device label and IFU, and contact the manufacturer for additional information.
What's being recalled
Companies: International Medical Industries, Inc., 2981 Gateway Drive, Pompano Beach, Florida, United States, 33069.
How to identify it
Affected products: Tamper Evident Additive Port Cap; Lot or serial number: 58203; Model or catalogue number: 21-01
Affected products: Tamper Evident Additive Port Cap; Lot or serial number: 58590; Model or catalogue number: 21-01
Affected products: Tamper Evident Additive Port Cap; Lot or serial number: 57325; Model or catalogue number: 21-01
Affected products: Tamper Evident Additive Port Cap; Lot or serial number: 56586; Model or catalogue number: 21-01
The hazard
The recall was initiated by IMI following their internal discovery that the corrugated shipper box contains incorrect compatibility information. All other information on the box label is correct, including the device label and IFU. Users are advised to not discard or return the device as it is safe to use, and to verify compatibility using the device label and IFU, not the shipper box.
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)