CanadaHEALON EndoCoat PRO (model/catalogue 10-3000-12) from Johnson & Johnson Surgical Vision, Inc., lots UA32371, UA32303, UP31203, UP31205 and UA32292 is subject to a voluntary recall. The recall follows reports of difficulty inserting the ultra‑thin 25g orange cannula; the product does not need to be removed or returned and may continue to be used when following the notice’s insertion instructions, and contact the manufacturer for more information.
What's being recalled
Companies: Johnson & Johnson Surgical Vision, Inc., 31 Technology Drive, Irvine, California, United States, 92618.
How to identify it
Affected products: HEALON EndoCoat PRO; Lot or serial number: UA32371; Model or catalogue number: 10-3000-12
Affected products: HEALON EndoCoat PRO; Lot or serial number: UA32303; Model or catalogue number: 10-3000-12
Affected products: HEALON EndoCoat PRO; Lot or serial number: UP31203; Model or catalogue number: 10-3000-12
Affected products: HEALON EndoCoat PRO; Lot or serial number: UP31205; Model or catalogue number: 10-3000-12
Affected products: HEALON EndoCoat PRO; Lot or serial number: UA32292; Model or catalogue number: 10-3000-12
The hazard
Johnson & Johnson Surgical Vision, Inc. is issuing a voluntary recall notice for HEALON EndoCoat™ PRO to inform customers of reports involving difficulty with insertion of the ultra-thin 25g orange cannula. This notice is intended to communicate the potential risks associated with cannula insertion and provide additional clarification regarding insertion technique to support the safe and effective use of the product. This recall does not require removal or return of the product from the market. When used in accordance with the instructions provided in this notice, the product may continue to be used as intended.
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