CLASS II Device recall · Reported 21 Aug 2013 · FDA Enforcement Report
Two-Lumen CVC Kit with Blue Flex Tip Catheter recalled
Arrow International is recalling Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter, distributed in 10 states. The recall was initiated on 31 Jul 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1965-2013
- FDA event ID
- 65829
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jul 2013
- FDA classified
- 14 Aug 2013
- Reported
- 21 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 31 Jul 2013 | Recall initiated by company | |
| 14 Aug 2013 | Classified by FDA | +14 days |
| 21 Aug 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
Product as listed by the FDA
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Where it was distributed
AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
AlabamaArizonaConnecticutIllinoisKansasNorth CarolinaNew JerseyPennsylvaniaRhode IslandVirginia
Questions about this recall
Is Two-Lumen CVC Kit with Blue Flex Tip Catheter recalled?
Yes. Arrow International recalled Two-Lumen CVC Kit with Blue Flex Tip Catheter on 31 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-1965-2013.
Why was it recalled?
Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
Which lots are affected?
Catalog # AK-17702-CDC, lot # RF2083258
Where was it sold?
AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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