BARDPORT M.R.I. Hard Base, X-PORT isp M.R.I. & POWERPORT isp M.R.I. Implantable Port (2019-09-27)
- Starting date:
- September 27, 2019
- Posting date:
- October 25, 2019
- 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-71363
Last updated: 2019-10-25
Affected Products
- BARDPORT M.R.I. Hard Base Implantable Port
- X-PORT isp M.R.I. Implantable Port
- POWERPORT isp M.R.I. Implantable Port
Reason
The identified product code/lot number combinations may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6FR catheter instead of the correct barb tip for a 9.6FR catheter.
Affected products
A. BARDPORT M.R.I. Hard Base Implantable Port
Lot or serial number
RECR1431
Model or catalog number
604550
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
B. X-PORT isp M.R.I. Implantable Port
Lot or serial number
RECR1508
Model or catalog number
607550
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
C. POWERPORT isp M.R.I. Implantable Port
Lot or serial number
- RECR0983
- RECR1885
- RECR2220
- RECS0030
- RECS2758
Model or catalog number
1859660
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES