—#150156

Product

HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external contamination.

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K895268
Affected lot / code info: Lot # 16F15C0114, 16F15D0003, 16F15A0072, 16F15F0031, 16F15F0090, 16F15H0037, 16F16B0001, 16F16B0014, 16F16C0056, 16F16C0079, 16F16C0109, 16F16E0004, 16F16E0030

Why it was recalled

Labeling inconsistency

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Arrow sent an Urgent Medical Device Recall Notification letter dated September 20, 2016, to all affected customers via FedEx 2-day air. The letter identified the problem and provided instructions to immediately discontinue use and quarantine any products with the associated lot numbers indicated in the letter. If product was found, customers were asked to complete the Recall Acknowledgement Form and a Customer Service Rep will issue a Return Goods Authorization (RGA) Number for the product's return. Disposition of recalled product will be scrapped. For further questions, please call (610) 378-0131

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: Nationwide distribution

Timeline

Recall initiated: 2016-09-02
Terminated: 2020-02-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150156. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.