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Lower risk Medical device recall · FDA · Published October 24, 2017

Arrow Pneumothorax Kit Recall: Packaging Not Fully Sealed

Arrow recalls Pneumothorax Kit (AK 01500 CA 0150: Packaging may not be completely sealed. Consumers should check packaging for seal integrity.

🇺🇸 FDA recall #Z-1299-2018Medical deviceArrow ›
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Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607
✎ GovInfoNow plain-language explainer

Arrow is recalling its Pneumothorax Kit (model AK 01500) because the packaging might not be sealed properly. This could lead to contamination or improper use of the medical device. Read more at govinfonow.com/recall/72695-arrow-pneumothorax-kit-recall-packaging-not-fully-sealed.

Source Summary by GovInfoNow · govinfonow.com/recall/72695-arrow-pneumothorax-kit-recall-packaging-not-fully-sealed · Updated September 14, 2026 · FDA enforcement record: FDA #Z-1299-2018

Cite this page

“Arrow Pneumothorax Kit Recall: Packaging Not Fully Sealed.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72695-arrow-pneumothorax-kit-recall-packaging-not-fully-sealed. Based on FDA recall #Z-1299-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1299-2018%22&limit=1).

The FDA announced on 2017-10-24 that Arrow International Inc. is recalling Pneumothorax Kits because the product packaging may not be completely sealed, according to the FDA.

How to tell if you have it

  • Brand: Arrow
  • Product: Pneumothorax Kit
  • Model numbers: AK 01500, CA 01500

The hazard

The recall is due to the risk that product packaging may not be completely sealed, according to the FDA.

Context

GovInfoNow's records show Arrow International Inc. has 52 other recalls on record since 2017-06-01. Other recent recalls of similar products include Arrow Arterial Kits and Trays (2024-07-26), Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Recall (2024-04-29), ARROW QuickFlash Radial Artery Catheter Recall (2024-02-12), Arrow Medical Kits Recall (2026-04-21), Arrow Recalls Catheter Kits with Possible Drug Contamination Risk (2026-04-21), and Arrow Medical Drainage Kits Recall (2026-04-21).

How to tell if you have this one

Check the packaging for the model AK 01500. The product was sold in California and other regions. The recall covers specific medical kits used for pneumothorax treatment.

  • Brand
    Arrow
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationally
Recall numberProduct, codes & lotsQuantity
Z-1297-2018Large Volume Abdominal Paracentesis Kit; AK 0037630,577 eaches
Z-1298-2018ArrowClarke" PleuraSeal¿ Thoracentesis Kit; AK01000 AK-01000-J AK-01000-T ASK-01000-CHPN/A
Z-1299-2018Pneumothorax Kit; AK 01500 CA 01500N/A
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging Seal

    Inspect the packaging for a fully sealed container. If the seal is broken or missing, do not use the kit.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationally” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: Oct 24, 201712. FDA classified it Class II: Apr 3, 201823. Published in FDA’s Enforcement Report: Apr 11, 201834. FDA terminated the recall: Apr 17, 2020420172020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-1299-2018 (October 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1299-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 14, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA