XCELA PICC WITH PASV VALVE TECHNOLOGY, SINGLE LUMEN, IR KIT, BIOFLOW PICC MST-70 KIT, BIOFLOW PICC IR-175 KIT, PICC CONVENIENCE KIT (2018-05-10)
- Starting date:
- May 10, 2019
- Posting date:
- August 2, 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-70573
Last updated: 2019-08-02
Affected Products
A. XCELA PICC WITH PASV VALVE TECHNOLOGY, SINGLE LUMEN, IR KIT
B. BIOFLO PICC MST-70 KIT
C. BIOFLO PICC IR-145 KIT
D. PICC CONVENIENCE KIT
Reason
AngioDynamics, Inc., Is conducting a medical device recall to the end user level based on information received from Galt Medical Corp., the manufacturer of certain introducers sheaths included within AngioDynamics Procedure Kits. Galt Medical Corp. has determined that the products listed in their 2-May-2018 recall notification, "might contain unsafe levels of bacterial endotoxins (pyrogens) that were introduced during a manufacturing step." As stated in the Recall Notification from Galt Medical, "Bacterial Endotoxins, also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient. AngioDynamics has confirmed that introducer sheaths affected by this recall have been included within AngioDynamics Procedure Kits which have been distributed to end users. AngioDynamics began distributing product affected by this recall on February 28, 2018 worldwide.
Affected products
A. XCELA PICC WITH PASV VALVE TECHNOLOGY, SINGLE LUMEN, IR KIT
Lot or serial number
5303187
Model or catalog number
H965251240
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
B. BIOFLO PICC MST-70 KIT
Lot or serial number
5303177
Model or catalog number
H965458710
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
C. BIOFLO PICC IR-145 KIT
Lot or serial number
5301752
5304983
Model or catalog number
H965458720
H965458820
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
D. PICC CONVENIENCE KIT
Lot or serial number
5299826
5300582
5312185
5312582
5316398
Model or catalog number
H96560M7009361
H96560M7015311
H96560M7015321
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES