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Health product recall

Pressure Injectable PICC Kit

Starting date:
June 1, 2017
Posting date:
June 21, 2017
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-63692

Reason

Arrow International is recalling the product referenced above because these finished good kits may contain 5 FR peel-away sheaths instead of the required 4 FR peel-away sheaths. Using a 5 FR sheath instead of a 4 FR sheath could cause excessive bleeding after insertion of the device.

Affected products

Pressure Injectable PICC Kit

Lot or serial number

23F16M0263

Model or catalog number

CDA-35041-HPK1A

Companies

Manufacturer
Arrow International Inc.
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES