FDA Medical Device Recalls (openFDA)
Arrow International Inc: ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring
- Recall number
- Z-0182-2018
- Recalling firm
- Arrow International Inc
- Product
- ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring
- Status
- Terminated
- Initiated
- 2017-06-01
- Posted
- not on file
- Terminated
- 2020-04-13
- Reason
- There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
- Root cause
- Mixed-up of materials/components
- Action
- Arrow International sent an Urgent Medical Device Recall Notification letter dated June 1, 2017, and Recall Acknowledgement Form to their domestic consignees via FedEx 2-day. Customers were advised to immediately inspect stock, discontinue use and quarantine any products with the product codes and lot numbers listed, so that the affected products can be returned to Arrow. To return product, 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 the firm to document the amount of product you have on hand for return. A customer service representative will the customer with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. If you 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. This will allow the company to document your receipt of the letter. Customers that have any questions can contact their local sales representative or Customer Service at 1-866-246-6990.
- Quantity
- not on file
- Distribution
- Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD
- Lot, serial or model codes
- Lot/Batch Number: 23F16L0021
- 510(k) numbers
- ["K113277"]
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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