CanadaMaquet Cardiopulmonary GmbH CTP tubing sets (including Cabaret 25 Kg model BO‑HQV 59206, multiple Perfusion Pack lots for model BEQ‑HQV 52700‑1, HL Pack model BEQ‑HQV 46904, and OHI Perfusion Pack model BO‑HQV 55004 — see manufacturer lot numbers listed in the notice) are affected and can be identified by the listed model/catalogue and lot or serial numbers. The recall was issued because the sterile barrier was found compromised (Tyvek lid opened) in multiple customer complaints. Consignees are being asked to return all unused affected product and contact the manufacturer for additional information.
What's being recalled
Companies: Maquet Cardiopulmonary Gmbh, Kehler Strasse 31, Rastatt, Germany, 76437.
How to identify it
Affected products: Cabaret 25 Kg; Lot or serial number: 3000419748; Model or catalogue number: BO-HQV 59206
Affected products: Perfusion Pack; Lot or serial number: 3000407529; Model or catalogue number: BEQ-HQV 52700-1
Affected products: Perfusion Pack; Lot or serial number: 3000415791; Model or catalogue number: BEQ-HQV 52700-1
Affected products: Perfusion Pack; Lot or serial number: 3000460078; Model or catalogue number: BEQ-HQV 52700-1
Affected products: Perfusion Pack; Lot or serial number: 3000491063; Model or catalogue number: BEQ-HQV 52700-1
Affected products: Perfusion Pack; Lot or serial number: 3000468700; Model or catalogue number: BEQ-HQV 52700-1
Affected products: Perfusion Pack; Lot or serial number: 3000460082; Model or catalogue number: BEQ-HQV 52700-1
Affected products: Perfusion Pack; Lot or serial number: 3000407530; Model or catalogue number: BEQ-HQV 52700-1
Affected products: Perfusion Pack; Lot or serial number: 3000491064; Model or catalogue number: BEQ-HQV 52700-1
Affected products: HL Pack With HL 20; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: BEQ-HQV 46904
Affected products: OHI Perfusion Pack; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: BO-HQV 55004
The hazard
The manufacturer became aware of this issue due to six customer complaint reports. It was found that the sterile barrier was compromised, as the Tyvek lid was found opened prior to use. No harm to any person was reported. An internal investigation has confirmed that all affected products show a consistent similar defect pattern occurring at the same sealing area and were manufactured using the same tool. Therefore, this FSCA is limited to all sterile products within shelf-life manufactured using the same tool. Consignees will be asked to confirm receipt of the field action notification. Consignees will be asked to return all unused, affected sold product from consignee locations.
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