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Pressure Injectable Picc Kit
- Starting date:
- July 26, 2017
- Posting date:
- September 5, 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-64406
Reason
Arrow International is recalling the referenced product because these finished good kits may contain incorrect components. Kits that should contain a 5 FR 2-lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2-lumen catheter. This labeling issue may cause a delay in treatment while a replacement catheter is obtained.
Affected products
Pressure Injectable Picc Kit
Lot or serial number
- 13F16A0089
- 13F16A0180
- 13F17B0290
- 23F16F0614
- 23F16M0059
- 23F17A0038
- 23F17A0040
Model or catalog number
- CDA-35041-HPK1A
- CDC-35041-VPS
- CDC-35052-VPS
- PR-35041-HPHNM
Companies
- Manufacturer
-
Arrow International Inc.
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES