Lower riskMedical device recall · FDA · Published May 23, 2018
Arrow Percutaneous Sheath Kit Recall: Latex Risk in Catheter Kits
Arrow recalls Percutaneous Sheath Introducer Kits for 7-7.5 Fr. catheters due to latex content despite label claiming latex-free. Affected kits may cause allergic reactions in sensitive users.
“Arrow Percutaneous Sheath Kit Recall: Latex Risk in Catheter Kits.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70992-arrow-percutaneous-sheath-kit-recall-latex-risk-in-catheter-kits. Based on FDA recall #Z-2576-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2576-2018%22&limit=1).
The FDA announced on May 23, 2018, that Arrow International Inc. recalled Percutaneous Sheath Introducer Kits because the product contains dry natural rubber latex despite labeling it as latex-free. The recall affects 60 units distributed in Puerto Rico.
How to tell if you have it
Brand: Arrow
Product: Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide)
REF: ES-09807
Lot/Batch Number: 13F18A0037
Expiration Date/Expected Life: Apr 2019
The hazard
The product contains dry natural rubber latex, which contradicts the label stating it is latex-free. This discrepancy poses a risk to individuals with latex allergies.
Context
GovInfoNow's records show Arrow International Inc. has 52 other recalls on record since June 1, 2017. Recent brand recalls include Arrow Arterial Kits and Trays packaging issues (July 26, 2024), the FiberOptix Intra-Aortic Balloon Catheter Kit risk (April 29, 2024), and the QuickFlash Radial Artery Catheter recall (Feb. 12, 2024). Other recent recalls of similar products include Arrow Recalls Catheter Kits with Possible Drug Contamination Risk (April 21, 2026), Arrow Percutaneous Sheath Introducer Recall: Incorrect Adhesive Manufacturing (March 11, 2026), and Arrow CVC Kits Recall: Risk of Serious Injuries from Contaminated Medication (April 21, 2026).
How to tell if you have this one
Check for the kit model REF ES-09807. The product is for 7-7.5 Fr. catheters with an 8 Fr. 10 cm sheath length. Lot/Batch Number 13F18A0037 was produced until April 2019.
Brand
Arrow
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the kit model REF ES-09807 and lot/batch number 13F18A0037 on the packaging.
Where it went and when
Where it was distributed
Distributed in Puerto Rico.
Listed by the agency
Not listed
FDA distribution: “Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Puerto Rico.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2576-2018 (May 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2576-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.