FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.
- Recall number
- Z-1823-2012
- Recalling firm
- Arrow International Inc
- Product
- Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.
- Status
- Terminated
- Initiated
- 2012-06-07
- Posted
- 2012-06-19
- Terminated
- 2014-04-03
- Reason
- Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.
- Root cause
- Nonconforming Material/Component
- Action
- Arrow International sent a Urgent Medical Device Recall Notification letter dated June 11, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following action: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot numbers listed. 2. To return product complete the enclosed Recall Acknowledgement Form and fax to 1-800-343-2935, Attn: Customer Service. This will allow us to document the amount of the 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 Arrow International. 3. If you have no affected stock, please complete t he enclosed Recall Acknowledgment Form and fax it to 1-800-343-2935, Attn: Customer Service. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-800-343-2935.
- Quantity
- 1,085
- Distribution
- USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.
- Lot, serial or model codes
- Lot number RF2033361
- 510(k) numbers
- ["K071538"]
- PMA numbers
- not on file
- Product code
- FOZ
- 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
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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