Recall Z-0602-2018— Arrow International Inc

Name: FDA recall Z-0602-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-25

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-07-25, terminated 2018-08-29. It names one FDA 510(k) clearance: K113277. Product: ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.. Reason: 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 may cause a delay in treatment while a replacement catheter is obtained..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-07-25
Terminated: 2018-08-29
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K113277 — ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITSArrow International, Inc.·cleared 2012-06-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.

Reason for recall

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 may cause a delay in treatment while a replacement catheter is obtained.

Data sourced from openFDA. This site is unofficial and independent of the FDA.