FDA Medical Device Recalls (openFDA)
Arrow International Inc: ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
- Recall number
- Z-1080-2015
- Recalling firm
- Arrow International Inc
- Product
- ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
- Status
- Terminated
- Initiated
- 2015-01-05
- Posted
- 2015-02-10
- Terminated
- 2018-07-17
- Reason
- The product labeling does not specify the 5 year shelf life of the product.
- Root cause
- Labeling design
- Action
- Urgent Medical Device Recall Notifications, dated January 2015, were sent to direct accounts that identified the product, problem, and actions to be taken. Customers were asked to discontinue use and return affected product.
- Quantity
- 63022
- Distribution
- Distribution US Nationwide, Canada and Mexico.
- Lot, serial or model codes
- Product number AN-05501, Lot numbers: 23F13J0530, RF2108954, RF6127264, RF8045530, RF0021370, RF3014600, RF6127624, RF8070744, RF0035171, RF3026989, RF7031498, RF8083748, RF0050648, RF5084669, RF7043570, RF8096949, RF0075647, RF5094931, RF7088907, RF8123534, RF0092301, RF5106225, RF7090151, RF9015869, RF2021938, RF5118327, RF7102346, RF9030002, RF2044557, RF5120725, RF7113197, RF9071402, RF2058276, RF6081852, RF8018337, RF9098526, RF2083791, RF6092570, RF8020947, and RF9113319.
- 510(k) numbers
- K884552
- PMA numbers
- not on file
- Product code
- CAZ
- 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