Arrow International Recalls Percutaneous Sheath Introducer Kits Due to Latex Labeling Error
Arrow International is recalling 60 units of Percutaneous Sheath Introducer Kits because the product contains dry natural rubber latex but is labeled as latex-free.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a labeling error regarding a common allergen (latex) on a medical device, which fits the rubric criteria for High severity (allergen mislabeling on common allergens).
Plain-English summary
Arrow International Inc is recalling 60 units of Percutaneous Sheath Introducer Kits, Reference ES-09807, Lot 13F18A0037. The product is intended for use with 7 to 7.5 Fr. catheters to permit venous access and catheter introduction to the central circulation.
The recall was initiated because the product contains dry natural rubber latex, but the label incorrectly states that the product is latex-free. This labeling discrepancy poses a risk to patients with latex allergies.
The affected units were distributed in Puerto Rico. The expiration date for the recalled lot is April 2019. Consumers and healthcare providers should stop using the product and contact the manufacturer for further instructions.
The recalled product
- 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. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Vascular Access
- Affected units
- 60
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot/Batch Number: 13F18A0037 Expiration Date/Expected Life: Apr 2019
Distribution
Distributed in 1 state:
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