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 Recall Z-0331-2017 · Posted None
Advertisement
Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDQO
Date Initiated2016-09-02
Date Terminated2020-02-20
Product Quantity330 units in US and 1,031 units OUS
Reason for Recall
Labeling inconsistency
Firm Action
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
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement