Arrowgard Blue Plus Antimicrobial Multi-lumen Central… recallZ-1507-2014 · Arrow International Inc · initiated Jul 17, 2013
Class II Terminated All recalls posted in April 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM
FDA root cause category: Labeling False and Misleading
What the company is doing
Arrow International Inc, ("Arrow") sent a Urgent Medical Device Recall Notification dated July 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot number listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to : 1-866-804-9881. Attn: Customer Service. This will allow us to document the amount of product you have on hand for 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 the enclosed Recall Acknowledgement Form and fax it to : 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. For further questions please contact Arrow Customer Service at 1-800-343-2935.
Recall details
- Recall number
- Z-1507-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 17, 2013
- Posted by the FDA
- Apr 24, 2014
- Recalling firm
- Arrow International Inc
- Quantity
- 170
- Product code
- FOZ
- FDA submissions
- K993691
- Distribution
- US Distribution including the states of IA, OR, WV, MI, AZ, IL, PA, GA, DE, NC, LA, and VA.
Product description
Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
Code information (models, lots, serial numbers)
lot RF2110924
Other devices under the same FDA submission
14 devices cleared under K993691 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARROW IPN037069Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN037833Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN037836Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN038392Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN055804Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN916999Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPNB00080Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN030243Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days20 reports
- ARROW IPN030195Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days3 reports
- ARROW IPN030240Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- ARROW IPN030231Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 report
- ARROW IPN037089Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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