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4FR Single Lumen Pressure Injectable PICC (2015-10-05)
- Starting date:
- October 5, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55706
Affected Products
4FR Single Lumen Pressure Injectable PICC
Reason
There is a labelling inaccuracy in the instructions for use (IFU) and patient card. The IFU and patient card contained within the these products state the peripherally inserted central catheter (PICC) can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.
Affected products
4FR Single Lumen Pressure Injectable PICC
Lot or serial number
All lots.
Model or catalog number
CA-05041-HP
CA-05041-HPX
EU-04041-HPMSB
EU-05041-HPMSB
EU-05541-HPMSB
Companies
- Manufacturer
-
Arrow International Inc.
2400 Bernville Road
19605
Pennsylvania
UNITED STATES