Arrow Pediatric Catheter Kit Has Labeling Error: Recalled
Arrow recalls pediatric two-lumen central venous catheter kits with blue flextip catheters due to a labeling error in the lidstock showing reversed gauge values. This may cause incorrect gauge selection during medical procedures.
Lower-risk recall
Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.
Contact the company
What happened, in plain English
Arrow is recalling pediatric catheter kits with a labeling error in the lidstock that shows reversed gauge values. This could lead to incorrect catheter gauge selection during medical procedures, potentially causing complications. Read more at govinfonow.com/recall/67914-arrow-pediatric-catheter-kit-has-labeling-error-recalled.
Source Summary by GovInfoNow · govinfonow.com/recall/67914-arrow-pediatric-catheter-kit-has-labeling-error-recalled · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0053-2020
Cite this page
“Arrow Pediatric Catheter Kit Has Labeling Error: Recalled.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67914-arrow-pediatric-catheter-kit-has-labeling-error-recalled. Based on FDA recall #Z-0053-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0053-2020%22&limit=1).
Why it’s dangerous
The lidstock incorrectly displays the catheter gauge values in reverse. This could lead to selecting the wrong gauge size during medical procedures, which might cause complications like improper blood flow or tissue damage.
Who’s affected
Healthcare professionals using the specific pediatric catheter kits with the listed lot numbers for short-term central venous access. Patients receiving treatment with these kits may be at risk if incorrect gauge selection occurs.
How to tell if you have this one
Check for the product name 'Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter' and lot numbers 13F18C0374, 13F18H0580, 13F18D0504, 13F18L0507, 13F18E0380, 13F18L0714, 13F18G0180, 13F18L0936, or 13F18G0480.
- Brand
Arrow- Category
Medical device
What to do — step by step
Check Product Label
Look for the lot numbers listed in the recall notice to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0053-2020 (May 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0053-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.