FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
- Recall number
- Z-1325-2018
- Recalling firm
- Arrow International Inc
- Product
- Arrow Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
- Status
- Terminated
- Initiated
- 2017-12-22
- Posted
- not on file
- Terminated
- 2020-05-27
- Reason
- Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Root cause
- Process control
- Action
- The notification letter includes the following instructions for CUSTOMERS: 1. Discontinue use and quarantine any affected products. 2. Complete and return the Recall Acknowledgement Form to start return process. 3. Complete the Recall Acknowledgment Form if there is no product on hand. Instructions for DISTRIBUTORS: 1.Discontinue distribution and quarantine any affected products. 2. Communicate this recall to any customers with affected product. 3. Have the customers return any affected product to you with a completed Recall Acknowledgement Form. 4. Return affected products from inventory using the Recall Acknowledgement Form. 5. Once you have returned recalled products from your own inventory, and collected 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 return the form.
- Quantity
- not on file
- Distribution
- Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
- Lot, serial or model codes
- Lot Number: 13F17B0123
- 510(k) numbers
- ["K061289"]
- 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