Recalls / —

—#179016

Product

Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC

FDA product code

BSO — Catheter, Conduction, Anesthetic

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K140110

Affected lot / code info

Lot Number: 13F18B0063

Why it was recalled

Product lidstock contains the incorrect expiration date for the product

Root cause (FDA determination)

Incorrect or no expiration date

Action the firm took

Arrow issued Urgent Medical Device Notification dated 12/20/19 stating reason for recall, health risk and action take: 2. Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex. If an alternative approach is needed, contact Teleflex Customer Service for more information at 1-866-396-2111. 4. To return affected products from your inventory, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex. 5. Once you have completed returning all the recalled products from your own inventory and collecting and consolidating all the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com. This will allow us to document completion of the recall. 6. If you and your customers have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Foreign consignees,are notified through the international office.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern

Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA

Timeline

Recall initiated

2019-12-20

Terminated

2021-02-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #179016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.