CanadaNucletron B.V. Intrauterine Tube (4 mm diameter), identified by model/catalogue numbers listed in the recall (for example 152019-00, 152021-00 and 126016-01), is affected. The tip of the tube may detach and remain within a patient, and owners should contact the manufacturer for additional information at APPLICATION.SUPPORT.NA@ELEKTA.COM, +1 855 693 5358 or https://www.elekta.com.
What's being recalled
Companies: Nucletron B.V., Waardgelder 1, Veenendaal, Netherlands, 3905 TH.
How to identify it
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152019-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152021-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152008-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152015-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152018-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152005-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152007-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152012-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152014-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152009-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152010-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152011-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152013-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152016-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152020-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152022-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152017-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 152023-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126014-01
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126019-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126016-01
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126020-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126020-01
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126021-01
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126016-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126017-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126017-01
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126018-01
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126023-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126023-01
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126013-01
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126014-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126018-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126013-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126015-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126021-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126022-00
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126022-01
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126015-01
Affected products: Intrauterine Tube; Lot or serial number: Not applicable.; Model or catalogue number: 126019-01
The hazard
Elekta are informing customers of a safety concern regarding the detachment of the tip of the Intrauterine Tube (IU tube) with a 4mm diameter that remained within a patient.
What to do
Contact the manufacturer if you require additional information.
APPLICATION.SUPPORT.NA@ELEKTA.COM
TEL: +1 855 6935358
HTTPS://WWW.ELEKTA.COM
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)