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ACROBAT V Vacuum Off-Pump System (2014-08-18)
- Starting date:
- August 18, 2014
- Posting date:
- September 16, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41355
Recalled products
- ACROBAT V Vacuum Off-Pump System
Reason
An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to these products. As a result, there is a potential for the pouch integrity to be compromised, which may result in compromised sterility of the product. If the compromised product is used in surgery there is a potential risk of infection for the patient.
Affected products
A. ACROBAT V Vacuum Off-Pump System
Lot or serial number
- 25081832
- 25084722
- 25089063
- 25091907
- 25092783
- 25092968
- 25095207
- 25097068
- 25097679
Model or catalog number
- OM-9100S
Companies
- Manufacturer
-
Maquet Cardiovascular LLC.
45 Barbour pond Drive,
wayne
07470
UNITED STATES