Recalls / —

—#166781

Product

ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording

FDA product code

DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K945229

Affected lot / code info

Lot/Batch Number:16F18A0010 Use By: 2023-12-31

Why it was recalled

Products are labeled with an incorrect expiration date

Root cause (FDA determination)

Error in labeling

Action the firm took

Arrow International notified US consignee notification by letter on 30 JUL 2018 via FedEx 2-day mail. Account action: immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern

US in the state of PA

Timeline

Recall initiated

2018-07-30

Terminated

2019-07-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #166781. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.