The Recall Desk
ModerateFDA (Devices)·Z-1790-2019·Announced 2019-06-26

Arrow PICC Kit Recall Issued for Incorrect Expiration Date Labeling

Arrow International Inc. is recalling 190 units of Arrow PICC Kits due to incorrect expiration dates printed on the product.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Arrow International Inc. is recalling 190 units of Arrow PICC Kits pre-loaded with Arrow VPS Precision Stylet, Product Code ASK 45552 CRM. The recall was initiated because the product was labeled with an incorrect expiration date.

The affected products are identified by batch codes 13F17J0016 and 13F17M0213. The recall is classified as Class II by the U.S. Food and Drug Administration. The products were distributed nationwide and to foreign locations.

Healthcare facilities and distributors should stop using the affected products and contact Arrow International Inc. for instructions on how to return them. No specific instructions for individual consumers are provided in the source text, as these are medical devices typically used in clinical settings.

The recalled product

Product
Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Product Code: ASK 45552 CRM
Affected units
190

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 (2)

  • Batch Code:13F17J0016
  • 13F17M0213

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 36 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 36 products in this recall →