Arrow International Inc: Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1

Recall number

Z-1236-2020

Recalling firm

Arrow International Inc

Product

Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1

Status

Terminated

Initiated

2019-12-20

Posted

not on file

Terminated

2021-02-25

Reason

Product lidstock contains the incorrect expiration date for the product

Root cause

Incorrect or no expiration date

Action

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.

Quantity

250 units

Distribution

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

Lot, serial or model codes

Lot Number: 13F18A0527

510(k) numbers

["K140110"]

PMA numbers

not on file

Product code

BSO

Firm FEI

3015859709

Firm city

Reading

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy