FDA Medical Device Recalls (openFDA)
Arrow International Inc: EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04
- Recall number
- Z-1197-2020
- Recalling firm
- Arrow International Inc
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04
- Status
- Terminated
- Initiated
- 2020-01-15
- Posted
- 2020-01-24
- Terminated
- 2023-03-17
- Reason
- There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
- Root cause
- Other
- Action
- An Urgent Medical Device Recall notification letter dated 1/15/20 was sent to customers. Our records indicate you have received products that are subject to this field action. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately identify product, discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or 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 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 products to Teleflex Medical. 3. 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 us to document your receipt of this letter.
- Quantity
- 343,105 total
- Distribution
- The products were distributed to the following US states: AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
- Lot, serial or model codes
- Lots: 71F19B0678 71F19C1428 71F19E1149 71F19G0313 71F19J0072 71F19L0492 71F19B2751 71F19D0558 71F19E1781 71F19G2388 71F19J1370 71F19L0493 71F19C0778 71F19D2449 71F19F0737 71F19H1817 71F19K2849
- 510(k) numbers
- not on file
- 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