Custom Tubing Packs
Brand(s)
Last updated
Summary
Product
Custom Tubing Packs
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you need additional information.
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| CUSTOM PACK WITH SOFTLINE | 92285211 92287249 92287967 92291766 | BO-HQV 59203 BO-HQV 59205 BO-HQV 59206 |
| PERFUSION SET WITH SOFTLINE COATING | 92276990 92277050 92277198 92279893 92288233 | BO-H 55815 BO-H 55816 |
| PERFUSION TUBING PACK WITH BIOLINE COATING | More than 10 numbers, contact manufacturer. | BEQ-H 48715 BEQ-H 48730 BEQ-H 84702 |
| PERFUSION SET WITH BIOLINE COATING | More than 10 numbers, contact manufacturer. | Not Available |
Issue
|
The tubing sets are designed and labeled for 2 years shelf-life from the manufacturing date. However, during a review of the technical documentation of tubing sets, it was found out that there is not sufficient evidence to demonstrate the 2 year shelf life of three 3rd party components integrated into the tubing sets.
Recall start date: 2021-11-05 |
What you should do
Contact the manufacturer if you need additional information.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
|
MAQUET CARDIOPULMONARY GMBH KEHLER STRASSE 31, RASTATT GERMANY 76437 |
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63600
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