Recall Z-0844-2020 ยท DQX Wire, Guide, Catheter
Arrow International Inc
Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.
| Date | Dec 12, 2019 |
| Status | Open, Classified |
| Reason | The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit |
| Root cause | Labeling Change Control |
| Action | Arrow International issued an " Urgent Medical Device Recall Notice" to its US consignee on 12th Dec 2019 via FedEx 2-day mail. The letter states reason for recall, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instruction |
| Quantity | 80 eaches |
| Distribution | US distribution to SC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K810675 | ARROW RADIAL ARTERY CATHETERIZATION SET Arrow Intl., Inc., Mar 27, 1981 |